NCT00016055

Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: St. Luke's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma.

Detailed description

OBJECTIVES: * Determine the safety of interleukin-12-primed activated T cells (12ATC) and temozolomide in patients with metastatic melanoma. * Determine the maximum tolerated dose of 12ATC in this patient population. * Determine the clinical response of patients treated with this regimen. OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC. Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 patients experience dose-limiting toxicity. Patients are followed weekly for 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	lymphokine-activated killer cells
DRUG	temozolomide

Timeline

• Start date: 2000-11-01
• First posted: 2003-01-27
• Last updated: 2013-09-20

Locations

1 site across 1 country: United States