Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

NCT ID: NCT00019890

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2007-03-31

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.

Detailed Description

OBJECTIVES:

I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma.

PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells.

Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection.

Patients are randomized to the following treatment arms:

Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Patients are followed at 4 to 6 weeks.

PROJECTED ACCRUAL:

A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7 months.

Conditions

Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

dendritic cell-gp100-MART-1 antigen vaccine

Intervention Type: DRUG

sargramostim

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Patrick Hwu

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Other Identifiers

NCI-99-C-0132

Identifier Type: -

Identifier Source: secondary_id

CDR0000067277

Identifier Type: -

Identifier Source: org_study_id

NCT00001825

Identifier Type: -

Identifier Source: nct_alias