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Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens


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

Thank you

Trial Information

Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens


OBJECTIVES:

- Determine the clinical response to immunization using gp100:44-59 antigen peptide plus
gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with
metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.

- Determine the clinical response to immunization using gp100:44-59 antigen peptide alone
in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201
negative.

- Determine the immunologic response in patients treated with these regimens as measured
by changes in T-cell precursors from before to after treatment.

- Evaluate the toxicity profiles of these regimens in these patients.

OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status
and prior gp100:209-217 (210M) antigen peptide immunization:

- Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified
together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and
MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.

- Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients
receive treatment as in group 1.

- Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide):
Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.

- All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease
progression or unacceptable toxicity. Patients with complete response after 4 doses
receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed,
or partial response after 4 doses receive a maximum of 12 additional doses. Patients
with no response after 4 doses receive immunization with the same peptides and
interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1
day after each immunization.

Patients are followed at 3-4 weeks.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued
for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven metastatic melanoma that has failed standard treatment

- HLA-DRB1*0401 positive

- Known HLA-A0201 status

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

- AST or ALT less than 3 times normal

- Hepatitis B surface antigen negative

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No symptomatic cardiac disease

Immunologic:

- No autoimmune disease

- No primary or secondary immunodeficiency disease

- HIV negative

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active systemic infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunization to the entire gp100 molecule

- At least 3 weeks since prior gp100:209-217 antigen peptide

- At least 3 weeks since other prior biologic therapy

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 for cancer allowed

Other:

- At least 3 weeks since any prior therapy except surgery for cancer

Type of Study:

Interventional

Study Design:

Masking: Open Label, 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:

CDR0000067391

NCT ID:

NCT00019994

Start Date:

October 1999

Completion Date:

October 2007

Related Keywords:

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

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182