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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00019721

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 1999

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgery Branch	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00019721

Other Study ID Numbers:

CDR0000067051
NCI-99-C-0092
NCI-T99-0033
NCT00001808

First Posted:

Aug 7, 2003

Last Update Posted:

Jun 20, 2013

Last Verified:

Aug 1, 2002

Keywords provided by , ,

stage IV melanoma

recurrent melanoma

Additional relevant MeSH terms:

Melanoma

Aldesleukin

Freund's Adjuvant

Study Results

No Results Posted as of Jun 20, 2013