Biological Therapy in Treating Patients With Metastatic Melanoma

NCT ID: NCT00045149

Last Updated: 2010-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-06-30

Brief Summary

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then 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.

Detailed Description

OBJECTIVES:

Primary

• Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
• Determine the duration of in vivo persistence of this therapy in these patients.

Secondary

• Evaluate the antitumor effects of this therapy in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.

Patients are followed for 9 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma

• Stage IV disease
• HLA-A1, -A2, and -A3 positive
• MAGE-1 or -3 positive by histology
• Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
• No CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• Karnofsky 80-100%

Life expectancy

• More than 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 1.6 mg/dL
• SGOT ≤ 3 times upper limit of normal
• PT ≤ 1.5 times control

Renal

• Creatinine ≤ 2.0 mg/dL
• Calcium ≤ 12 mg/dL

Cardiovascular

• No congestive heart failure
• No clinically significant hypotension
• No symptoms of coronary artery disease
• No cardiac arrhythmias on electrocardiogram requiring drug therapy
• Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram

Pulmonary

• No clinically significant pulmonary dysfunction by medical history or physical examination
• FEV_1 ≥ 60% of normal
• DLCO ≥ 55% (corrected for hemoglobin)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No retinitis or choroiditis
• No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
• No systemic infection requiring chronic maintenance or suppressive therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)

Chemotherapy

• At least 3 weeks since prior standard or experimental chemotherapy
• 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed

Endocrine therapy

• No concurrent systemic steroids (except for toxicity management)

Radiotherapy

• At least 3 weeks since prior radiotherapy

Surgery

• Not specified

Other

• At least 3 weeks since prior immunosuppressive therapy
• No concurrent pentoxifylline
• No other concurrent investigational agents

• 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

NCT00029432

Identifier Type: -

Identifier Source: nct_alias

FHCRC-1588.00

Identifier Type: -

Identifier Source: secondary_id

NCI-H02-0091

Identifier Type: -

Identifier Source: secondary_id

CDR0000256451

Identifier Type: REGISTRY

Identifier Source: secondary_id

1588.00

Identifier Type: -

Identifier Source: org_study_id