Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill ovarian cancer cells. Interleukin-2 combined with white blood cells that are gene-modified to recognize and kill ovarian cancer cells may be an effective treatment for recurrent or residual ovarian cancer. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white blood cells in treating patients who have advanced ovarian epithelial cancer.


Study summary:

OBJECTIVES: - Determine the clinical response in patients with advanced ovarian epithelial cancer treated with intravenously administered allogeneic peripheral blood mononuclear cell-stimulated, gene-modified lymphocytes (MOv-PBL). - Evaluate the ability of intravenously administered MOv-PBL to traffic to sites of ovarian cancer. - Determine the duration of survival of transduced lymphocytes in the systemic circulation and at the tumor site in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified by eligibility to receive interleukin-2 (IL-2) (yes vs no). Patients undergo leukapheresis. The collected peripheral blood lymphocytes (PBLs) are stimulated with allogeneic peripheral blood mononuclear cells (PBMCs) followed by retroviral transduction with antiovarian cancer MOv-gamma chimeric receptor gene (MOv-PBL). MOv-PBL are then reinfused IV over 30-60 minutes followed by IL-2 IV over 15-30 minutes every 12 hours for up to 8 doses (if eligible). This course may be repeated at least once, beginning 2-3 weeks later. Patients receiving allogeneic PBMC-stimulated PBLs receive donor PBMCs subcutaneously at 1 and 8 days after each MOv-PBL infusion instead of IL-2. Cohorts of 3-6 patients in each stratum receive escalating doses of MOv-PBL until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients receive MOv-PBL, without IL-2, followed by immunization with donor PBMCs as above. Patients are followed at 4 and 8 weeks and then periodically for survival. PROJECTED ACCRUAL: Approximately 13-50 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven recurrent, resected recurrent, or residual ovarian epithelial cancer - Failed prior standard effective therapy including cisplatin/carboplatin or paclitaxel - Tumor positive for folate-binding protein by monoclonal antibody MOv18 binding - Measurable disease by CT scan, MRI, ultrasound, or physical exam OR - Minimal residual disease on laparotomy, laparoscopy, or peritoneal washings (i.e., disease not evaluable radiologically or on physical exam) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0 or 1 Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 9.0 g/dL - No coagulation disorder Hepatic: - Bilirubin no greater than 2.0 mg/dL - Other liver function tests less than 3 times upper limit of normal - Hepatitis B antigen negative Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No major cardiovascular illness - If history of ischemic heart disease, congestive heart failure, or cardiac arrhythmias, not eligible to receive interleukin-2 Pulmonary: - FEV_1 and DLCO greater than 70% predicted - No major respiratory illness Immunologic: - Must have an intact immune system as evidenced by a positive reaction to Candida albicans, mumps, or tetanus toxoid skin tests on a standard anergy panel - HIV negative - No active systemic infection Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 2 weeks since prior biologic therapy Chemotherapy: - See Disease Characteristics - More than 2 weeks since prior chemotherapy Endocrine therapy: - More than 2 weeks since prior endocrine therapy - No concurrent steroids Radiotherapy: - More than 2 weeks since prior radiotherapy Surgery: - See Disease Characteristics - Prior debulking allowed


NCT ID:

NCT00019136


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.