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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
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 |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
| 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, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Kim A. Margolin, MD 206-288-7374 | |
| Principal Investigator: | Kim A. Margolin, MD | Seattle Cancer Care Alliance |
More Information
| Study ID Numbers: | CDR0000587997, FHCRC-07156, CHNMC-07156 |
| Study First Received: | February 29, 2008 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00627601 History of Changes |
| Health Authority: | Unspecified |
|
ovarian dysgerminoma ovarian immature teratoma ovarian mature teratoma recurrent ovarian germ cell tumor stage III ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian monodermal and highly specialized teratoma recurrent malignant testicular germ cell tumor testicular seminoma testicular embryonal carcinoma testicular choriocarcinoma testicular yolk sac tumor testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and yolk sac tumor |
testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor and teratoma with seminoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and seminoma recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma recurrent extragonadal germ cell tumor adult teratoma testicular immature teratoma testicular mature teratoma stage III malignant testicular germ cell tumor |
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Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Cyclophosphamide Genital Diseases, Female Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Alkylating Agents Etoposide |
Nervous System Neoplasms Endocrine Gland Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Mitosis Modulators Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Ifosfamide |