Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019383

Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide Biological: tyrosinase-related protein-1	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin Sargramostim Tyrosinase Freund's adjuvant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 1998

Detailed Description:

OBJECTIVES:

Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants.
Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients.

OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).

Patients are assigned to 1 of 4 vaccine groups:

Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment.

At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued.

Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses.

Patients are followed for 4-6 weeks.

PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven refractory metastatic melanoma
- Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive
Measurable disease

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance Status:

ECOG 0-1

Life Expectancy:

Greater than 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 90,000/mm^3
No coagulation disorder

Hepatic:

AST or ALT less than 2 times upper limit of normal
Bilirubin no greater than 1.6 mg/dL

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No major cardiovascular disease

Pulmonary:

No major respiratory disease

Other:

Not pregnant
Fertile patients must use effective contraception
HIV negative
Hepatitis B surface antigen negative
No known allergy to Montanide ISA-51
No active systemic infection
No immunodeficiency disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 3 weeks since prior biologic therapy
No concurrent biologic therapy

Chemotherapy:

At least 3 weeks since prior chemotherapy
No concurrent chemotherapy

Endocrine therapy:

At least 3 weeks since prior endocrine therapy
No concurrent steroid therapy or other endocrine therapy

Radiotherapy:

At least 3 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery:

Prior or concurrent surgery for melanoma allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019383

Locations

United States, Maryland
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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065915, NCI-98-C-0022, NCI-T97-0088
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019383 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on November 09, 2009