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 GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002786
• Other study ID #: 1017.01
• Secondary ID: FHCRC-1017.01NCI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 1999
• Last updated: May 6, 2010
• Start date: October 1995
• Est. completion date: March 2006

Study information

• Verified date: May 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00029419

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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,