Full Text View
Tabular View
No Study Results Posted
Related Studies
Gene Therapy and Biological Therapy in Treating Patients With Ovarian Epithelial Cancer
This study has been completed.
Study NCT00019136   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
February 1997
 
 
 
Complete list of historical versions of study NCT00019136 on ClinicalTrials.gov Archive Site
 
 
 
Gene Therapy and Biological Therapy in Treating Patients With Ovarian Epithelial Cancer
TREATMENT OF PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER USING ANTI-CD3 STIMULATED PERIPHERAL BLOOD LYMPHOCYTES TRANSDUCED WITH A GENE ENCODING A CHIMERIC T-CELL RECEPTOR REACTIVE WITH FOLATE BINDING PROTEIN

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.

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.

Phase I
Interventional
Treatment
Ovarian Cancer
  • Biological: MOv-gamma chimeric receptor gene
  • Biological: aldesleukin
  • Biological: therapeutic allogeneic lymphocytes
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019136
 
CDR0000064488, NCI-96-C-0011, NCI-T95-0040N
National Cancer Institute (NCI)
 
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP