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| Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00627601 |
Purpose
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, 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.
PURPOSE: This phase II trial is studying how well giving high-dose chemotherapy together with stem cell transplant works in treating patients with germ cell tumors.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor |
Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: paclitaxel Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | Ifosfamide Cyclophosphamide Carboplatin Filgrastim Etoposide Paclitaxel Etoposide phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Tandem High Dose Chemotherapy With Autologous Hematopoietic Cell Transplant for Selected Germ Cell Cancer Patients |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease status (chemo-responsive first relapse vs marker negative after chemotherapy but viable tumor at surgical resection vs all other patients [second relapse, responding to third-line therapy, and no history of absolute refractoriness to platinum-based therapy] vs patients with mediastinal primary nonseminomatous germ cell tumors not in subsequent relapse and not refractory to first-line therapy) and prior therapy with paclitaxel and ifosfamide-containing regimens (yes vs no).
Tandem high-dose chemotherapy and PBSC reinfusion:
After completion of study treatment, patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then yearly thereafter.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed seminoma or nonseminoma germ cell cancer
Tumor-free but remain at high risk OR meeting 1 of the following criteria:
Chemo-responsive first relapse*
Patients in first relapse responding to second-line therapy with a taxane- or non-taxane-based regimen
All other patients meeting the following criteria:
History of CNS metastases allowed provided the patient has been treated and off steroids with stable post-radiotherapy neurological status for at least 1 month and seizure-free for at least 1 month with therapeutic anticonvulsant levels prior to registration
PATIENT CHARACTERISTICS:
No prior invasive malignancy except for adequately treated nonmelanoma skin cancer or other cancers from which the patient has been disease-free for at least 5 years
FEV_1 ≥ 2 liters or 75% of lower limit of predicted value
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |||||
| City of Hope Comprehensive Cancer Center | Recruiting | ||||
| Duarte, California, United States, 91010-3000 | |||||
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |||||
| Beckman Research Institute |
| National Cancer Institute (NCI) |
| Principal Investigator: | Kim Allyson Margolin, MD | Beckman Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000587997, CHNMC-07156 |
| First Received: | February 29, 2008 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00627601 |
| Health Authority: | Unspecified |
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