Biological Therapy in Treating Patients With Metastatic Melanoma

NCT00002786 | Completed Phase 1

• 4 other identifiers: 1017.01FHCRC-1017.01NCI-V96-0920CDR0000064846
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

therapeutic tumor infiltrating lymphocytes BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histopathologically proven metastatic melanoma * No CNS metastases * HLA-A2 positive * Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI) * Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 80-100% 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 * Bilirubin no greater than 1.6 mg/dL * SGOT no greater than 150 IU (or no greater than 3 times normal) * Prothrombin time no greater than 1.5 times control Renal * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 12 mg/dL Cardiovascular * No congestive heart failure * No clinically significant hypotension * No symptoms of coronary artery disease * No arrhythmia on EKG requiring drug therapy Pulmonary * No severe chronic obstructive pulmonary disease * FEV\_1 at least 1.0 L * DLCO at least 45% of predicted Other * No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study * No systemic infection requiring chronic maintenance or suppressive therapy * HIV negative * No history of seizures * No retinitis or choroiditis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use adequate contraception * Peripheral blood samples available weekly for 4 consecutive weeks PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since other prior immunotherapy Chemotherapy * 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease * At least 4 weeks since prior standard or investigational chemotherapy Endocrine therapy * At least 4 weeks since prior steroid therapy Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since other prior investigational drug therapy and recovered

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

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

• 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: November 1, 1999
• First Posted: May 26, 2003
• Study Start: October 1, 1995
• Study Completion: March 1, 2006
• Last Updated: May 10, 2010

Record last verified: 2010-05

Locations

US (1)