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Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma

NCT01005472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-08-03

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.

Phase II was never conducted due to toxicity in phase I.

PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.

Conditions

Interventions

DRUG

sunitinib malate

DRUG

temozolomide

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Bartosz Chmielowski, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-01
Primary Completion
2018-01-17
Completion
2018-01-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01005472 on ClinicalTrials.gov