Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00085397 | Unknown Phase 2

• 2 other identifiers: CDR0000369699DFCI-03123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Immune response

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.

Biological: autologous dendritic cell-tumor fusion vaccine

Arm II

EXPERIMENTAL

Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.

Biological: gp100 antigen; Biological: therapeutic autologous dendritic cells

Interventions

autologous dendritic cell-tumor fusion vaccine BIOLOGICAL

Given subcutaneously

Arm I

gp100 antigen BIOLOGICAL

Given IV

Arm II

therapeutic autologous dendritic cells BIOLOGICAL

Given IV

Arm II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous melanoma * Stage III or IV disease * Recurrent or de novo stage III disease allowed if disease is unresectable and no definitive treatment is available * gp100- and HLA-A201-positive * Surgically accessible tumor, defined by 1 of the following: * Pulmonary lesions approachable by thoracoscopic procedure * Skin or superficial soft tissue or lymph node lesions amenable to resection under local anesthesia * Malignant ascites or pleural effusion * Measurable disease in addition to surgically accessible tumor \> 2.0 cm * No CNS metastases * No mucosal or ocular melanoma PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * WBC \> 3,000/mm\^3 * Platelet count \> 75,000/mm\^3 Hepatic * Bilirubin \< 2.0 mg/dL Renal * Creatinine \< 2.0 mg/dL Immunologic * No active infection requiring treatment * No clinically significant autoimmune disorder * No immune deficiency disorder * HIV negative Other * Antecubital vein accessible for leukapheresis * No other malignancy within the past 5 years except nonmelanoma skin cancer or squamous cell carcinoma in situ of the cervix * No pre-existing comorbid disease that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior melanoma vaccine therapy * More than 6 weeks since prior immunotherapy Chemotherapy * No prior chemotherapy for metastatic melanoma Endocrine therapy * No concurrent corticosteroids Radiotherapy * More than 6 weeks since prior radiotherapy Surgery * Not specified Other * No concurrent systemic immunosuppressive therapy

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

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

• Frank Haluska, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Last Updated: February 9, 2009

Record last verified: 2008-04

Locations

US (3)