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| Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00408590 |
Purpose
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cavity Cancer |
Biological: carcinoembryonic antigen-expressing measles virus Genetic: reverse transcriptase-polymerase chain reaction |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Trial of Intraperitoneal Administration of a CEA-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer |
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive recombinant carcinoembryonic antigen-expressing measles virus (MV-CEA) intraperitoneally over 30 minutes on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MV-CEA 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.
Peripheral blood mononuclear cells are collected at baseline and periodically during and after treatment to assess viremia. Throat gargle and urine specimens are assessed periodically during course 1 for viral shedding by reverse transcriptase-polymerase chain reaction (RT-PCR). Peritoneal aspirate is tested at baseline and periodically during treatment for viral replication by RT-PCR, co-culture with Vero cells, and measles virus N-specific mRNA in situ hybridization.
After completion of study therapy, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer or primary peritoneal cavity cancer
Any of the following histologic epithelial cell types allowed:
No known standard therapy that is potentially curative or capable of extending life expectancy exists
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent oral or systemic corticosteroids
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
| Investigator: | Lynn C. Hartmann, MD | Mayo Clinic |
| Investigator: | William A. Cliby, MD | Mayo Clinic |
| Investigator: | Val J. Lowe, MD | Mayo Clinic |
| Investigator: | J. William Charboneau, MD | Mayo Clinic |
| Investigator: | Brian Mullan, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000515008, MAYO-MC0117 |
| Study First Received: | December 6, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00408590 History of Changes |
| Health Authority: | Unspecified |
|
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma peritoneal cavity cancer ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma |
ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer Brenner tumor |
|
Cystadenocarcinoma, Serous Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Measles Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Carcinoma, Endometrioid |
Recurrence Carcinoma Virus Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Adenocarcinoma Endocrine Gland Neoplasms |
|
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms |
Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |