flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2007-03-31

Brief Summary

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RATIONALE: The drug flt3L may stimulate a person's immune system and help to kill tumor cells. Vaccines made from melanoma cells may make the body build an immune response to and kill their tumor cells.

PURPOSE: Phase II trial to study the effectiveness of flt3L with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer.

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Detailed Description

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OBJECTIVES: I. Evaluate the immunologic and biologic activity of flt3 ligand (Flt3L) alone in patients with metastatic renal cell cancer or HLA-A2.1 negative melanoma.

II. Evaluate the immunologic and biologic activity of Flt3L alone or in combination with melanoma peptide immunization (MART-1, gp100:209-217, gp100:280-288, and tyrosinase) in patients with metastatic, HLA-A2.1 positive melanoma.

PROTOCOL OUTLINE: Patients are assigned to 1 of 3 treatment groups:

Group 1 (renal cell cancer): Patients receive Flt3 ligand (Flt3L) subcutaneously (SQ) alone on days 1-14.

Group 2 (HLA-A2.1 negative melanoma): Patients receive Flt3L SQ alone on days 1-14.

Group 3 (HLA-A2.1 positive melanoma): Patients may receive either Flt3L SQ alone on days 1-14 or in combination with melanoma peptide immunization. Patients may receive melanoma peptide immunization comprised of MART-1 immunodominant peptide, gp100:209-217, gp100:280-288, and tyrosinase peptide emulsified in Montanide ISA-51 SQ on day 12 of Flt3L administration.

Treatment repeats every 4 weeks for 2 courses. Patients with no response or minor response may receive 2 additional courses. Patients with disease progression after 1 course are removed from study.

PROJECTED ACCRUAL:

Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study within 16 months.

Conditions

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Stage IV Melanoma Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer Recurrent Melanoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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flt3 ligand

Intervention Type DRUG

gp100 antigen

Intervention Type DRUG

MART-1 antigen

Intervention Type DRUG

Montanide ISA-51

Intervention Type DRUG

tyrosinase peptide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven metastatic melanoma or renal cell cancer Patients receiving melanoma peptide immunizations must be HLA-A2.1 positive Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: No concurrent systemic steroid therapy At least 1 month since prior steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: Prior surgery allowed Other: Greater than 1 month since prior therapy --Patient Characteristics-- Age: Not specified Performance Status: ECOG 0-1 Life Expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Negative pregnancy test HIV negative Hepatitis B surface antigen negative No allergic reaction to Montanide ISA-51 No active systemic infection No prior autoimmune disorders

Eligible Sex

ALL

Accepts Healthy Volunteers

No