Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

NCT ID: NCT00101257

Last Updated: 2010-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2010-03-31

Brief Summary

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing.

PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer.
• Determine the duration of in vivo persistence of this drug in these patients.

Secondary

• Determine the antitumor effect of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis for collection of T cells. Responder T cells are stimulated in vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed with NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive antigen-specific T cells IV over 30 minutes.

Cohorts of 3-6 patients receive escalating doses of autologous CD4-positive antigen-specific T cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4, 8, and 12 weeks and then periodically thereafter for survival.

PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

therapeutic autologous lymphocytes

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Pulmonary

• FEV_1 ≥ 60% of predicted*
• DLCO ≥ 55%* NOTE: *Patients with clinically significant pulmonary dysfunction only

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No active infection
• No oral temperature > 38.2°C 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., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior standard or experimental chemotherapy

Endocrine therapy

• No concurrent systemic corticosteroids except for treatment-related toxicity

Radiotherapy

• At least 3 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 3 weeks since prior immunosuppressive therapy
• More than 3 weeks since prior investigational drugs and recovered
• No other concurrent investigational agents
• No concurrent pentoxifylline

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

Sponsors

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-1942.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000402870

Identifier Type: REGISTRY

Identifier Source: secondary_id

1942.00

Identifier Type: -

Identifier Source: org_study_id