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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxe1
National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual
chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2
Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.
Immunotherapy with monoclonal antibodies1 expand
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. Type: Interventional Start Date: Nov 2023 |
A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Effica1
Novartis Pharmaceuticals
Sjogrens Syndrome
The purpose of this study is to measure the long-term safety and tolerability of
ianalumab in participants with Sjogrens syndrome who have previously completed treatment
from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302
[NCT05349214]).
- The study treatmen1 expand
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 [NCT05350072] or CVAY736A2302 [NCT05349214]). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe (PFS) or in a 2 mL autoinjector (AI) for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up. Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe or a 2 mL autoinjector. Participants will be given the opportunity to self-inject at home on some visits after receiving training. Type: Interventional Start Date: Oct 2023 |
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients W1
Children's Oncology Group
Acute Myeloid Leukemia
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated
daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed
acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such
as daunorubicin, cytarabine, and1 expand
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone. Type: Interventional Start Date: Jul 2020 |
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and1
Marzieh Salehi
Spinal Cord Injuries
Type 2 Diabetes
It is not known whether a new diabetes drug, semaglutide, is an effective treatment for
type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk
for this condition. Therefore, this study looks at the effect of semaglutide on glucose
levels in the body and other informa1 expand
It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity. Type: Interventional Start Date: Apr 2025 |
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement o1
MediWound Ltd
Venous Leg Ulcer (VLU)
The main objective of this study is:
To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo
control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU). expand
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU). Type: Interventional Start Date: Apr 2025 |
KIOS Mobile App Evaluation
The University of Texas Health Science Center at San Antonio
Opioid Use Disorder
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of
opioid use disorder (OUD). expand
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD). Type: Interventional Start Date: May 2024 |
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilep1
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of refractory focal epilepsy. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: Mar 2024 |
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan1
Novartis Pharmaceuticals
Prostatic Neoplasm
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone
(Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor
Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant
prostate cancer and no evidence of metastasis in1 expand
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans). Approximately 120 participants will be randomized. Type: Interventional Start Date: Jan 2024 |
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leuk1
Children's Oncology Group
B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Down Syndrome
Myeloid Leukemia Associated With Down Syndrome
This study attempts to learn more about the health of persons with Down syndrome after
treatment for acute leukemia. Children with Down syndrome are at increased risk for side
effects during treatment for acute leukemia, but it is unclear of their risk for
long-term effects of cancer treatment. By1 expand
This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life. Type: Observational Start Date: Nov 2023 |
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In1
Stemline Therapeutics, Inc.
Breast Cancer
Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine
the RP2D of elacestrant when administered in combination with alpelisib, everolimus,
palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the
efficacy and safety of the various1 expand
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. Type: Interventional Start Date: Jan 2023 |
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Eli Lilly and Company
Breast Neoplasms
The main purpose of this study is to measure how well imlunestrant works compared to
standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for1 expand
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Type: Interventional Start Date: Oct 2022 |
Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer1
National Cancer Institute (NCI)
Metastatic Papillary Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase II trial compares the effect of atezolizumab in combination with usual
treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell
carcinoma that has spread from where it first started (primary site) to other places in
the body (metastatic). Papillary renal ce1 expand
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread from where it first started (primary site) to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of tumor cells. Combination therapy with atezolizumab and cabozantinib may shrink the tumor and allow a longer survival time in patients with metastatic renal cell carcinoma. Type: Interventional Start Date: Mar 2023 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration
of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac
arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion of children that at1 expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
MILDĀ® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients1 expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer D1
Alliance for Clinical Trials in Oncology
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Ann Arbor Stage I Lymphoma
Ann Arbor Stage II Lymphoma
Ann Arbor Stage III Lymphoma
This study collects blood and tissue samples from patients with cancer and without cancer
to evaluate tests for early cancer detection. Collecting and storing samples of blood and
tissue from patients with and without cancer to study in the laboratory may help
researchers develop tests for the earl1 expand
This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers. Type: Observational Start Date: Aug 2022 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Tr1
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide therapy selection. Decipher
score is based on the activity of 22 genes in prostate tumor and may predict how likely
it is for recurrent prostate cancer to spread (metastasize) to other parts of the body.
Decipher score in this study is used1 expand
This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. Type: Interventional Start Date: Dec 2021 |
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
BPGbio
Glioblastoma
Glioblastoma Multiforme
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will
assess the effects of adding BPM31510 onto a conventional treatment framework of RT and
concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma. expand
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma. Type: Interventional Start Date: Aug 2022 |
Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer
The University of Texas Health Science Center at San Antonio
Gastric Cancer
This protocol is a single-institution feasibility study to identify the molecular and
epidemiological risk factors in the development of gastric cancer in high-risk
predominantly Hispanic South Texas population. The study is broken down into two main
parts: 1) To identify molecular differences in g1 expand
This protocol is a single-institution feasibility study to identify the molecular and epidemiological risk factors in the development of gastric cancer in high-risk predominantly Hispanic South Texas population. The study is broken down into two main parts: 1) To identify molecular differences in gastric adenocarcinoma (GAC) between Non-Hispanics and Hispanics, stratified by age, and in benign, pre-malignant, and malignant gastric lesions; and 2) To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes linked to the development of GAC. Type: Observational Start Date: Jan 2021 |
Financial Toxicity and Quality of Life in Patients With TGCT
The University of Texas Health Science Center at San Antonio
Testicular Neoplasm
This is a cross-sectional, observational study employing validated questionnaires to
investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As
background, TGCTs are the most common malignancies among men from age 15-35. Treatment is
highly curative, but often consists o1 expand
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors. Type: Observational Start Date: Mar 2023 |
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
NextCure, Inc.
Ovarian Cancer
Breast Cancer
Endometrial Cancer
Biliary Tract Cancer
Non-Small Cell Lung Cancer
This is an open-label, phase 1, dose escalation and dose expansion study to determine
safety and tolerability, and to determine the maximum tolerated dose and / or recommended
phase 2 dose of LNCB74 in participants with advanced solid tumors. expand
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors. Type: Interventional Start Date: Jan 2025 |
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabet1
The University of Texas Health Science Center at San Antonio
Type 2 Diabetes (Adult Onset)
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism
of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared
to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes
mellitus. expand
The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus. Type: Interventional Start Date: Nov 2024 |
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for Primary Centr1
Children's Oncology Group
Central Nervous System Carcinoma
This phase III trial compares memantine to placebo in treating patients with primary
central nervous system tumors. Memantine may block receptors (parts of nerve cells) in
the brain known to contribute to a decline in cognitive function. Giving memantine may
make a difference in cognitive function1 expand
This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors. Type: Interventional Start Date: May 2022 |
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Medi1
National Cancer Institute (NCI)
Primary Mediastinal Large B-Cell Lymphoma
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may
help the body's immune system atta1 expand
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL. Type: Interventional Start Date: Oct 2021 |
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Chi1
LLS PedAL Initiative, LLC
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia Post Cytotoxic Therapy
Juvenile Myelomonocytic Leukemia
Mixed Phenotype Acute Leukemia
This study aims to use clinical and biological characteristics of acute leukemias to
screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone
marrow and blood from patients with leukemia that has come back after treatment or is
difficult to treat may provide informat1 expand
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults. Type: Interventional Start Date: Apr 2022 |
A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
Children's Oncology Group
Central Nervous System Nongerminomatous Germ Cell Tumor
Choriocarcinoma
Embryonal Carcinoma
Immature Teratoma
Malignant Teratoma
This phase II trial studies the best approach to combine chemotherapy and radiation
therapy (RT) based on the patient's response to induction chemotherapy in patients with
non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the
brain or body (localized). This study has1 expand
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT. Type: Interventional Start Date: Jul 2021 |
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