Germ Cell Tumor Clinical Trial
Official title:
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, 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. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below. Primary Objective: 1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT) Secondary Objectives: 1. To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 2. To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP 3. To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT 4. To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group). 5. To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS. Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06133543 -
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
|
N/A | |
Terminated |
NCT00369291 -
CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant
|
Phase 1 | |
Terminated |
NCT00198172 -
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors
|
Phase 2 | |
Recruiting |
NCT05874063 -
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
|
Phase 3 | |
Completed |
NCT03194906 -
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors
|
Phase 2 | |
Completed |
NCT01466231 -
Everolimus in Refractory Testicular Germ Cell Cancer
|
Phase 2 | |
Recruiting |
NCT04791228 -
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03418844 -
Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
|
N/A | |
Recruiting |
NCT05889585 -
Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated With High-dose Chemotherapy and Autologous Stem Cell Transplant
|
||
Recruiting |
NCT05394675 -
A Study of DS-9606a in Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT03067181 -
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
|
Phase 3 | |
Withdrawn |
NCT03960151 -
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
|
Phase 2 | |
Active, not recruiting |
NCT03158064 -
Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors
|
Phase 2 | |
Completed |
NCT03950830 -
Disulfiram and Cisplatin in Refractory TGCTs.
|
Phase 2 | |
Recruiting |
NCT00898755 -
Collecting and Storing Tissue From Young Patients With Cancer
|
||
Recruiting |
NCT04804007 -
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
|
Phase 2 | |
Terminated |
NCT02988843 -
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
|
Phase 2 | |
Recruiting |
NCT05259605 -
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
|
||
Active, not recruiting |
NCT03638167 -
EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors
|
Phase 1 | |
Recruiting |
NCT04308330 -
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
|
Phase 1 |