Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00014092
• Lead Sponsor: Saint Francis Hospital

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.

Detailed Description

OBJECTIVES:

* Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.

* Determine the safety and tolerability of this regimen in this patient population.

* Determine the changes in quality of life over time in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.

Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.

Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2001-04-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2003-12
• Status Verified: 2004-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Saint Francis Memorial Hospital; 🇺🇸 San Francisco, California, United States

John Wayne Cancer Institute at Saint John's Health Center; 🇺🇸 Santa Monica, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States