NCT00070096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 24, 2013

Status Verified

April 1, 2006

First QC Date

October 3, 2003

Last Update Submit

June 21, 2013

Conditions

Brain and Central Nervous System TumorsExtragonadal Germ Cell TumorOvarian CancerTesticular Germ Cell Tumor

Keywords

stage IV ovarian germ cell tumorrecurrent ovarian germ cell tumoradult central nervous system germ cell tumorrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumortesticular seminomatesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and seminomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and yolk sac tumortesticular choriocarcinomatesticular embryonal carcinoma and seminomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinomatesticular yolk sac tumor and teratoma with seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumorrecurrent extragonadal non-seminomatous germ cell tumorrecurrent extragonadal seminomastage IV extragonadal non-seminomatous germ cell tumorstage IV extragonadal seminomarecurrent extragonadal germ cell tumortesticular immature teratomatesticular mature teratoma

Outcome Measures

Primary Outcomes (2)

  • Efficacy

  • Safety

Interventions

ixabepiloneDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsOvarian NeoplasmsTesticular Germ Cell TumorTesticular NeoplasmsSeminomaCarcinoma, EmbryonalTeratomaEndodermal Sinus Tumor

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeMesonephroma

Study Officials

  • Gnanamba V. Kondagunta, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 1, 2003

Study Completion

June 1, 2007

Last Updated

June 24, 2013

Record last verified: 2006-04

Locations

US(1)