Biological Therapy in Treating Patients With Metastatic Melanoma

NCT ID: NCT00002786

Last Updated: 2010-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-10-31
• Study Completion Date: 2006-03-31

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.

Detailed Description

OBJECTIVES:

• Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.
• Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.
• Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.

OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for approximately 1 year after the last infusion.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Cassian Yee, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

FHCRC-1017.01

Identifier Type: -

Identifier Source: secondary_id

NCI-V96-0920

Identifier Type: -

Identifier Source: secondary_id

CDR0000064846

Identifier Type: REGISTRY

Identifier Source: secondary_id

1017.01

Identifier Type: -

Identifier Source: org_study_id

NCT00029419

Identifier Type: -

Identifier Source: nct_alias