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

Primary Purpose

Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
therapeutic autologous lymphocytes
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Safety and toxicity
Duration of in vivo persistence
Antitumor effects

Secondary Outcome Measures

Full Information

First Posted
January 7, 2005
Last Updated
May 5, 2010
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00101257
Brief Title
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic autologous lymphocytes
Primary Outcome Measure Information:
Title
Safety and toxicity
Title
Duration of in vivo persistence
Title
Antitumor effects

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassian Yee, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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

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