Anti-gp100 Cells Plus ALVAC gp100 Vaccine to Treat Advanced Melanoma

Summary

Background:

* gp100 is a protein that is often found in melanoma tumors.
* An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 cells are created in the laboratory using the patient's own tumor cells or blood cells.
* The treatment procedure also uses a vaccine called plaque purified canarypox vector (ALVAC) gp100, made from a virus that ordinarily infects canaries and is modified to carry a copy of the gp100 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti gp 100 cells.

Objectives:

-To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in treating patients with advanced melanoma.

Eligibility:

-Patients with metastatic melanoma for whom standard treatments have not been effective.

Design:

* Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment.
* Patients have 7 days of chemotherapy to prepare the immune system for receiving the gp100 cells.
* Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of gp100 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses.
* After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

Conditions

• Metastatic Melanoma
• Skin Cancer

Interventions

DRUG

cyclophosphamide

60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour

DRUG

fludarabine phosphate

25 mg/m\^2 day intravenous piggy back over 30 minutes for 5 days

BIOLOGICAL

Aldesleukin

720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days.

BIOLOGICAL

ALVAC gp100 Vaccine

0.5 ml containing a target dose of 10\^7 CCID50 (with a range of approximately 10\^6,4 to 10\^7,9/mL) of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10\^7 CCID50/2mL)

BIOLOGICAL

anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL)

3 x 10\^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10\^8 cells will be given.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Steven A Rosenberg, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• United States

Study Locations