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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002931 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer |
Estimated Enrollment: | 12 |
Study Start Date: | February 1997 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Responsible Party: | City of Hope Comprehensive Cancer Center ( George Somlo ) |
Study ID Numbers: | CDR0000065365, CHNMC-96126, NCI-G97-1136 |
Study First Received: | November 1, 1999 |
Last Updated: | June 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00002931 History of Changes |
Health Authority: | United States: Federal Government |
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 ovarian germ cell tumor recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma recurrent extragonadal germ cell tumor adult teratoma testicular immature teratoma testicular mature teratoma ovarian immature teratoma ovarian mature teratoma ovarian monodermal and highly specialized teratoma stage III malignant testicular germ cell tumor stage IV ovarian germ cell tumor stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma |
Gonadal Disorders Seminoma Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Etoposide phosphate Genital Diseases, Female Neoplasms, Germ Cell and Embryonal Ovarian Cancer Alkylating Agents Etoposide Nervous System Neoplasms Endocrine Gland Neoplasms Extragonadal Germ Cell Tumor Ovarian Neoplasms |
Testicular Cancer Malignant Germ Cell Tumor Choriocarcinoma Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Testicular Neoplasms Recurrence Carcinoma Ifosfamide Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Nonseminomatous Germ Cell Tumor |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Central Nervous System Neoplasms Genital Diseases, Female Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Alkylating Agents 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 Pharmacologic Actions Adnexal Diseases Neoplasms Ifosfamide Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Teratoma |