Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
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ClinicalTrials.gov Identifier: NCT00070096 |
Recruitment Status :
Completed
First Posted : October 7, 2003
Last Update Posted : June 24, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor | Drug: ixabepilone | Phase 2 |
OBJECTIVES:
- Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
- Determine the safety of this drug in these patients.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 29 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL |
Study Start Date : | August 2003 |
Actual Study Completion Date : | June 2007 |

- Efficacy
- Safety

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:
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Measurable metastatic disease by one of the following methods:
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Radiography
- If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
- Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
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Previously treated progressive disease meeting 1 of the following criteria:
- Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
- Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
- Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- No other concurrent cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent experimental or commercial anticancer medications or therapies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070096
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 |
ClinicalTrials.gov Identifier: | NCT00070096 |
Other Study ID Numbers: |
CDR0000329992 MSKCC-03041 NCI-6022 |
First Posted: | October 7, 2003 Key Record Dates |
Last Update Posted: | June 24, 2013 |
Last Verified: | April 2006 |
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 |
Neoplasms Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Central Nervous System Neoplasms Testicular Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Nervous System Diseases Genital Neoplasms, Male Testicular Diseases |