Not Signed In -
Muromonab-CD3 |
Orthoclone OKT3 |
Clinical Trial: 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
This study has been completed.
Purpose
Patients with measurable recurrent disease are treated on Regimen A; those with minimal residual disease are treated on Regimen B.
Regimen A: Gene Therapy/Biological Response Modifier Therapy. Peripheral blood lymphocytes (PBL) stimulated with OKT3 (anti-CD3) monoclonal antibody and retrovirally transduced with the anti-ovarian cancer MOv-gamma chimeric receptor gene (MOv-PBL); with Interleukin-2 (Chiron), IL-2, NSC-373364. Intravenous administration.
Regimen B: Gene Therapy/Biological Response Modifier Therapy. MOv-PBL; with IL-2. Peritoneal administration.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ovarian Neoplasm | Drug: IL-2 Drug: OKT3 | Phase I |
MedlinePlus related topics: Ovarian Cancer
Study Type: Interventional
Study Design: Treatment, Safety
Official Title: Treatment of Patients with Advanced Epithelial Ovarian Cancer Using Peripheral Blood Lymphocytes Transduced with a Gene Encoding a Chimeric T-Cell Receptor Reactive with Folate Binding Protein
Expected Total Enrollment: 50
Study start: November 6, 1995; Study completion: September 23, 2004
Patients with recurrent, evaluable ovarian cancer will receive intravenous therapy with autologous peripheral blood lymphocytes that have been genetically modified to recognize an ovarian cancer-associated antigen (MOv-PBL). The duration of survival in the systemic circulation and at the tumor site will be evaluated. Patients will also be evaluated for a clinical response.
Eligibility
Genders Eligible for Study: Female
Criteria
Patients must have a biopsy-proven recurrent, resected recurrent, or residual epithelial ovarian cancer that has recurred following standard effective therapy including cisplatin/carboplatin or paclitaxel containing regimens.
Age greater than or equal to 18 years.
Clinical performance status of ECOG 0 or 1.
Serum creatinine less than or equal to 2.0 mg/dl.
Prior to infusion of MOv-PBL, more than 2 weeks must have elapsed since any prior therapy, besides surgical debulking.
Women of child bearing potential must have a negative pregnancy test.
Patients must have tumor that is positive on immunohistochemistry or FACS analysis for MOv18.
Hgb greater than 9.0, WBC greater than 3000, and platelets greater than 100,000.
Bilirubin 2.0 mg/dl or less and LFTs less than 3 times the upper limit of normal.
FEV1 greater than 70% and DLCO greater than 70% predicted.
Have an intact immune system, evidenced by a positive reaction to Candida Albicans skin tests, mumps skin test, or tetanus toxoid skin test on a standard anergy panel.
EXCLUSION CRITERIA
Require steroid therapy
Are seropositive for HIV antibody.
Are seropositive for hepatitis B antigen.
Have active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular or respiratory systems are not eligible.
Location Information
Maryland
National Cancer Institute (NCI), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
More Information
Publications
Hwu P, Shafer GE, Treisman J, Schindler DG, Gross G, Cowherd R, Rosenberg SA, Eshhar Z. Lysis of ovarian cancer cells by human lymphocytes redirected with a chimeric gene composed of an antibody variable region and the Fc receptor gamma chain. J Exp Med. 1993 Jul 1;178(1):361-6.
Hwu P, Yang JC, Cowherd R, Treisman J, Shafer GE, Eshhar Z, Rosenberg SA. In vivo antitumor activity of T cells redirected with chimeric antibody/T-cell receptor genes. Cancer Res. 1995 Aug 1;55(15):3369-73.
Hwu P, Yannelli J, Kriegler M, Anderson WF, Perez C, Chiang Y, Schwarz S, Cowherd R, Delgado C, Mule J, et al. Functional and molecular characterization of tumor-infiltrating lymphocytes transduced with tumor necrosis factor-alpha cDNA for the gene therapy of cancer in humans. J Immunol. 1993 May 1;150(9):4104-15.
Record last reviewed: September 23, 2004
Last Updated: September 24, 2004
Record first received: November 3, 1999
ClinicalTrials.gov Identifier: NCT00001494
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Muromonab-CD3 (Drug Digest)
- Orthoclone OKT3 (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
