NCT00014092

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

Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Saint Francis Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	recombinant interferon alfa
BIOLOGICAL	sargramostim
DRUG	temozolomide

Timeline

• Start date: 1999-12-01
• Completion: 2003-12-01
• First posted: 2003-01-27
• Last updated: 2013-03-26

Locations

3 sites across 1 country: United States