Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal

NCT00003229 | Completed Phase 1

• 6 other identifiers: CDR0000066097DUMC-719975DUMC-0932-99-5R2DUMC-759-99-5R2UVA-HIC-7454NCI-G98-1398
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill the tumor cells. PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from white blood cells and melanoma cells in treating patients with metastatic melanoma who are undergoing surgery for lymph node and tumor removal.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

gp100 antigen BIOLOGICAL

tyrosinase peptide BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma involving cervical, axillary, inguinal, groin, or iliac lymph nodes All gross disease is resected at the time of surgical lymphadenectomy No distant metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.4 mg/dL AST or ALT no greater than 1.5 times normal No active hepatitis Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No congestive heart failure, unstable angina, or current symptomatic arrhythmias Other: HIV negative No autoimmune diseases (e.g., lupus erythematosus, multiple sclerosis, or ankylosing spondylitis) No condition that would be considered as a contraindication for surgery Not pregnant or nursing Adequate contraception required for all fertile patients PRIOR CONCURRENT THERAPY: At least 4 weeks since prior therapy for melanoma Biologic therapy: At least 3 months since prior interferon therapy Chemotherapy: No active immunosuppression due to prior chemotherapy Endocrine therapy: No active immunosuppression due to steroid therapy Radiotherapy: Not specified Surgery: Not specified

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

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

Study Officials

• Hilliard F. Seigler, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 25, 2004
• Study Start: July 1, 1997
• Primary Completion: April 1, 2000
• Study Completion: February 1, 2005
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

US (2)