Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070096
First received: October 3, 2003
Last updated: July 23, 2008
Last verified: April 2006
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Efficacy [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 29 |
| Study Start Date: | August 2003 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070096
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Gnanamba V. Kondagunta, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00070096 History of Changes |
| Other Study ID Numbers: | CDR0000329992, MSKCC-03041, NCI-6022 |
| Study First Received: | October 3, 2003 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Ovarian Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Endocrine Gland Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013