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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070096 |
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor |
Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL |
Estimated Enrollment: | 29 |
Study Start Date: | August 2003 |
OBJECTIVES:
OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
Measurable metastatic disease by one of the following methods:
Radiography
Previously treated progressive disease meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Gnanamba V. Kondagunta, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000329992, MSKCC-03041, NCI-6022 |
Study First Received: | October 3, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070096 |
Health Authority: | United States: Federal Government |
stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor adult central nervous system germ cell tumor recurrent malignant testicular germ cell tumor stage III malignant testicular germ cell tumor testicular seminoma testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and teratoma |
testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular yolk sac tumor and teratoma with seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma recurrent extragonadal germ cell tumor testicular immature teratoma testicular mature teratoma |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Epothilones Genital Neoplasms, Female Choriocarcinoma Endocrine System Diseases Seminoma Nonseminomatous germ cell tumor Urogenital Neoplasms Central Nervous System Neoplasms Testicular Neoplasms |
Ovarian Diseases Recurrence Carcinoma Genital Diseases, Female Cisplatin Neoplasms, Germ Cell and Embryonal Testicular cancer Endocrinopathy Teratoma Nervous System Neoplasms Extragonadal Germ Cell Tumor Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Nervous System Diseases Antimitotic Agents Pharmacologic Actions Adnexal Diseases |