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


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000067051

NCT ID:

NCT00019721

Start Date:

April 1999

Completion Date:

June 2003

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892