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

NCT00019214 | Completed Phase 1

• 4 other identifiers: CDR0000065234NCI-97-C-0046NCI-97-C-0019NCI-T96-0046N
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells. PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma

Interventions

MART-1 antigen BIOLOGICAL

aldesleukin BIOLOGICAL

gp100 antigen BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma that has failed standard effective therapy * Measurable or evaluable disease * HLA-A2 positive PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * AST/ALT less than 4 times upper limit of normal * Negative hepatitis B surface antigen * No coagulation disorder Renal: * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance greater than 75 mL/min Cardiovascular: * No major cardiovascular disease Pulmonary: * No major respiratory disease Other: * No major immunological disease * No penicillin allergy * HIV negative * No active systemic infection * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 4 weeks since prior steroid therapy and recovered Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since any other prior therapy and recovered

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)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; aldesleukin

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

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors

Study Officials

• James C. Yang, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 1997
• Study Completion: July 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2005-01

Locations

US (1)