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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| 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 an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer (measles virus vaccine therapy study closed as of 06/02/2008).
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: carcinoembryonic antigen-expressing measles virus Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Intraperitoneal Administration of a) a CEA-Expressing Derivative, and b) a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer |
| Estimated Enrollment: | 46 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | July 2012 (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) or oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) 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 ( MV-CEA closed as of 06/02/2008).
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 ( MV-CEA closed as of 06/02/2008).
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.
Patients may undergo single photon emission computed tomography (SPECT/CT) imaging at baseline and periodically during study.
After completion of study therapy, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 46 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 |
Inclusion criteria:
The following laboratory values obtained ≤7 days prior to registration:
Exclusion criteria:
Any of the following prior therapies:
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
More Information
| Responsible Party: | Evanthia Galanis, M.D., Mayo Clinic IRB |
| ClinicalTrials.gov Identifier: | NCT00408590 History of Changes |
| Other Study ID Numbers: | CDR0000515008, P30CA015083, MC0117, 1260-03, NCI-2009-01199 |
| Study First Received: | December 6, 2006 |
| Last Updated: | September 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma primary peritoneal cavity cancer ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma |
ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer Brenner tumor |
|
Measles Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type |