Clinical trial NCT00070096: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-07
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gnanamba V. Kondagunta, MD
role: PRINCIPAL_INVESTIGATOR
References: