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

A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL

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.

Study Overview

• Status: Completed
• Conditions: Testicular Germ Cell Tumor; Ovarian Cancer; Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor
• Intervention / Treatment: Drug: ixabepilone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Efficacy

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gnanamba V. Kondagunta, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: October 3, 2003
• First Submitted That Met QC Criteria: October 6, 2003
• First Posted (Estimate): October 7, 2003

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Keywords: stage III malignant testicular germ cell tumor; adult central nervous system germ cell tumor; recurrent ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent malignant testicular germ cell tumor; testicular embryonal carcinoma; testicular choriocarcinoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and seminoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor and teratoma with seminoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and seminoma; 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; testicular seminoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Neoplasms; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: CDR0000329992; MSKCC-03041; NCI-6022