Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma

NCT00019383 | Completed Phase 2

• 3 other identifiers: CDR0000065915NCI-98-C-0022NCI-T97-0088
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

tyrosinase peptide BIOLOGICAL

tyrosinase-related protein-1 BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; incomplete Freund's adjuvant; sargramostim; tyrosinase-related protein-1

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: August 7, 2003
• Study Start: January 1, 1998
• Study Completion: June 1, 2003
• Last Updated: June 20, 2013

Record last verified: 2003-06

Locations

US (1)