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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070096
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:


  • 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.

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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

Primary Outcome Measures :
  1. Efficacy
  2. Safety

Information from the National Library of Medicine

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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


  • 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)



  • 16 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 2 times upper limit of normal


  • Creatinine no greater than 2.2 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • No active infection


Biologic therapy

  • No concurrent immunotherapy


  • See Disease Characteristics
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent experimental or commercial anticancer medications or therapies

Information from the National Library of Medicine

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 identifier (NCT number): NCT00070096

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00070096    
Other Study ID Numbers: CDR0000329992
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: April 2006
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:
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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