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

Ovarian Cancer Clinical Trial

Official title:

Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101257
• Other study ID #: 1942.00
• Secondary ID: FHCRC-1942.00CDR
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2005
• Last updated: May 5, 2010
• Start date: October 2004
• Est. completion date: March 2010

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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• therapeutic autologous lymphocytes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toxicity			Yes
Primary	Duration of in vivo persistence			No
Primary	Antitumor effects			No