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Temodar and Sutent as Therapy for Melanoma

NCT00304200 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2009-02-05

No results posted yet for this study

Summary

This study is designed to evaluate the safety and appropriate dose of the combination of Temodar and Sutent as first-line therapy for patients with metastatic malignant melanoma (Phase 1). Once the safety and appropriate dose is determined, additional patients will be studied at that dose to determine if there is clinical benefit as determined by the primary end-point of progression-free survival (PFS) at 6 months and additional secondary endpoints (Phase II).

Conditions

  • Metastatic Malignant Melanoma

Interventions

DRUG

Temozolomide and SU11248

First Cohort: Temozolomide 100 mg/m2 orally week 1 and week 3 of a 28-day cycle; SU11248, 25 mg/day orally on weeks 2, 3, and 4 or a 28 day cycle.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Northern California Melanoma Center

    lead OTHER

Principal Investigators

  • Lynn E. Spitler, MD · Northern California Melanoma Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-10-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00304200 on ClinicalTrials.gov