Vaccine Therapy in Treating Patients With Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Phase I Trial of a Dendritic Cell Vaccine for Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003665
• Other study ID #: NCI-2012-02292
• Secondary ID: UPCC-4697NCI-T98
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 27, 2013
• Start date: April 1999
• Est. completion date: November 2002

Study information

• Verified date: February 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.

Description:

OBJECTIVES:

I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine.

II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population.

OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms.

All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses.

Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.

Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

Patients are followed at 2 weeks and then monthly for 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

-Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1

PATIENT CHARACTERISTICS:

• Age: Over 18

• Performance status: ECOG 0-1

• Life expectancy: At least 2 months

• Platelet count at least 100,000/mm3

• INR no greater than 1.5 mg/dL

• No coagulopathies including thrombocytopenia

• Partial thromboplastin time no greater than 50 seconds

• No major cardiac illness

• No major respiratory illness

• No active systemic infection or other illness

• No peripheral vascular disease

• Not pregnant or nursing

• Effective contraception required of all fertile patients during and for one month after completion of treatment

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior immunotherapy

• No concurrent immunotherapy

• At least 30 days since prior chemotherapy

• No concurrent chemotherapy

• At least 30 days since prior radiotherapy

• No concurrent radiotherapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• dendritic cell-MART-1 peptide vaccine

• gp100 antigen

• therapeutic tumor infiltrating lymphocytes

• tyrosinase peptide

Locations

Country	Name	City	State
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,