Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:

Progressive* or persistent* disease during or after primary chemotherapy
Recurrent disease < 6 months after completion of primary therapy that had resulted in a complete response
Persistent* or recurrent disease after second-line or additional therapies NOTE: *Progression or persistence can be based on serological (CA 125 > 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings
Tumor expressing NY-ESO-1 determined by IHC or RT-PCR
HLA type expressing DPB*0401, DPB1*0201, DRB1*07
No CNS metastases

PATIENT CHARACTERISTICS:

Age

18 to 75

Performance status

Karnofsky 70-100%

Life expectancy

More than 16 weeks

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Creatinine ≤ 2.0 mg/dL

Cardiovascular

No congestive heart failure*
No clinically significant hypotension*
No symptoms of coronary artery disease*
No cardiac arrhythmias on EKG requiring drug therapy*
No history of cardiovascular disease*
No other significant cardiovascular abnormalities* NOTE: *Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT00101257

Recruitment Status:

Completed

Sponsor:

Fred Hutchinson Cancer Center

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There is 1 Location for this study

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Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT00101257

Recruitment Status:

Completed

Sponsor:


Fred Hutchinson Cancer Center

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