Biological Therapy in Treating Patients With Metastatic Melanoma

NCT00045357 | Completed Phase 1

• 4 other identifiers: 1585.00FHCRC-1585.00NCI-H02-0093CDR0000256867
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Interventions

therapeutic autologous lymphocytes 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 * HLA type expressing one of the following class II alleles: * DRB1\*0401 * DRB1\*0404 * DRB1\*1501 * DPB1\*0401 * DPB1\*0402 * Tumor expresses tyrosinase * Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed * No CNS metastases * Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 70-100% Life expectancy * More than 16 weeks Hematopoietic * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 30% Hepatic * SGOT no greater than 3 times upper limit of normal * INR no greater than 1.5 due to hepatic dysfunction * No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater Renal * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min * Calcium no greater than 12 mg/dL Cardiovascular * No significant cardiac abnormalities\*, defined by any 1 of the following: * Congestive heart failure * Clinically significant hypotension * Symptoms of coronary artery disease * Cardiac arrhythmias present on EKG requiring drug therapy NOTE: \*Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram Pulmonary * No clinically significant pulmonary dysfunction * FEV1 at least 1.0 L OR * FEV1 at least 60% * DLCO at least 55% (corrected for hemoglobin) Immunologic * No acquired or hereditary immunodeficiency * No autoimmune disease * No active infection * No oral temperature greater than 38.2 degrees C within the past 72 hours * No systemic infection requiring chronic maintenance or suppressive therapy * HIV negative Other * No retinitis or choroiditis * No history of seizures * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy) Chemotherapy * At least 4 weeks since prior chemotherapy (standard or experimental) and recovered Endocrine therapy * No concurrent systemic steroids except for toxicity management Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior immunosuppressive therapy * More than 4 weeks since prior experimental drugs and recovered * No concurrent pentoxifylline * No other concurrent investigational agents

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

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

• Cassian Yee, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: July 8, 2003
• Study Start: November 1, 2001
• Study Completion: August 1, 2008
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

US (1)