Biological Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045149
• Other study ID #: 1588.00
• Secondary ID: FHCRC-1588.00NCI
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2002
• Last updated: May 5, 2010
• Start date: October 2002
• Est. completion date: June 2005

Study information

• Verified date: May 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00029432

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• therapeutic tumor infiltrating lymphocytes

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,