search
Back to results

Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

Primary Purpose

Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Efficacy
Safety

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
June 21, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00070096
Brief Title
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
Official Title
A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ixabepilone
Primary Outcome Measure Information:
Title
Efficacy
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gnanamba V. Kondagunta, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

We'll reach out to this number within 24 hrs