Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Study Description

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Brief Summary:

RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

Condition or disease	Intervention/treatment	Phase
Melanoma (Skin)	Biological: aldesleukin; Biological: gp209-2M antigen; Biological: incomplete Freund's adjuvant	Phase 2

Detailed Description:

OBJECTIVES:

• Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.
• Determine the survival of infused cells with antitumor activity in these patients.

OUTLINE: This is a salvage regimen.

Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.

Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
Study Start Date :	November 1998
Actual Study Completion Date :	May 2003

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule
• Measurable or evaluable metastatic disease
• Must be HLA-A201 positive by standard HLA typing

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Greater than 3 months

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin greater than 8.0 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• ALT/AST less than 4 times upper limit of normal

Renal:

• Creatinine no greater than 1.6 mg/dL

Cardiovascular:

• For patients randomized to receive interleukin-2:

  • No major medical illnesses of the cardiovascular system

Pulmonary:

• For patients randomized to receive interleukin-2:

  • No major medical illnesses of the pulmonary system

Other:

• HIV negative
• Hepatitis B antigen negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• For patients randomized to receive interleukin-2:

  • No active systemic infection
  • No other major medical illnesses of immune system
  • No coagulation disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• No concurrent steroid therapy

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No concurrent active treatment of brain metastases

Contacts and Locations

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Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:	Steven A. Rosenberg, MD, PhD	NCI - Surgery Branch

More Information

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Publications:

Dudley ME, Wunderlich J, Nishimura MI, Yu D, Yang JC, Topalian SL, Schwartzentruber DJ, Hwu P, Marincola FM, Sherry R, Leitman SF, Rosenberg SA. Adoptive transfer of cloned melanoma-reactive T lymphocytes for the treatment of patients with metastatic melanoma. J Immunother. 2001 Jul-Aug;24(4):363-73.

ClinicalTrials.gov Identifier:	NCT00019487 History of Changes
Obsolete Identifiers:	NCT00001694
Other Study ID Numbers:	CDR0000066287; NCI-98-C-0095; NCI-T98-0012
First Posted:	January 27, 2003
Last Update Posted:	June 20, 2013
Last Verified:	March 2003

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma; recurrent melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Aldesleukin	Freund's Adjuvant; Antineoplastic Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs