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

Melanoma (Skin) Clinical Trial

Official title:

Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019721
• Other study ID #: CDR0000067051
• Secondary ID: NCI-99-C-0092NCI
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 18, 2013
• Start date: April 1999
• Est. completion date: June 2003

Study information

• Verified date: August 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.

Description:

OBJECTIVES:

• Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.

• Determine the efficacy of these peptides in patients who cannot receive IL-2.

• Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.

• Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.

• Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.

• Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a partially randomized study.

Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.

• Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).

• Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).

• Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.

• Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).

• Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.

Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.

Other known NCT identifiers

• NCT00001808

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma that has failed standard therapy

• Measurable disease

• HLA-A0201 positive

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 90,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)

• AST/ALT less than 3 times normal

• Hepatitis B surface antigen negative

• No coagulation disorder

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No major cardiovascular disease

• If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only

Pulmonary:

• No major respiratory disease

Other:

• Not pregnant

• Fertile patients must use effective contraception

• HIV negative

• No active systemic infection

• No autoimmune disease or immunodeficiency disease

• No primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy

• No prior MART-1 antigen immunization

Chemotherapy:

• At least 3 weeks since prior chemotherapy

Endocrine therapy:

• At least 3 weeks since prior endocrine therapy

• No concurrent steroid therapy

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Prior surgery allowed

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• MART-1 antigen

• aldesleukin

• gp100 antigen

• incomplete Freund's adjuvant

Locations

Country	Name	City	State
United States	Surgery Branch	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,