Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)
• Interventions: Drug: semaxanib; Drug: thalidomide

• Registration Number: NCT00017316
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

Detailed Description

OBJECTIVES:

I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.

II. Determine the quantitative and qualitative toxic effects of this regimen in these patients.

III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen.

V. Assess disease-free survival at 6 months of patients treated with this regimen.

OUTLINE:

Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2001-06-06
• Status Verified: 2002-08
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Primary Completion: 2003-09
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	semaxanib	Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm I	thalidomide	Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States