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


Phase 2
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Gnanamba V. Kondagunta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000329992

NCT ID:

NCT00070096

Start Date:

August 2003

Completion Date:

June 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • 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
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021