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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602277 |
RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: wild-type reovirus |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase ½ Study of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma |
Estimated Enrollment: | 70 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase I: Experimental
Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: wild-type reovirus
Given IV and intraperitoneally
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Phase II: Experimental
Patients undergo IP access port insertion before beginning treatment. Patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP (at the maximum tolerated dose determined in phase I) over 10 minutes on days 1 and 2. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: wild-type reovirus
Given IV and intraperitoneally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus followed by a phase II study.
NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3.
Prior to each IP wild-type reovirus administration, normal saline is administered through the IP catheter and withdrawn for correlative studies in courses 2 and 3 (phase I) or courses 1 and 2 (phase II). Patients also undergo a CT-guided percutaneous tumor biopsy on day 2 of course 3 (phase I or II). Samples are analyzed by immunohistochemistry, RT-PCR, and electron microscopy for the relevant molecular effects of wild-type reovirus on tumor and normal tissue.
After completion of study treatment, patients are followed for up to 12 weeks.
PROJECTED ACCRUAL: A total of 70 patients (up to 30 for phase I and 40 for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Recurrent disease after platinum-based chemotherapy
Must have experienced disease persistence during primary platinum-based therapy or recurrence within 12 months after completion of platinum-based chemotherapy ("platinum-refractory" or "platinum-resistant" disease)
Must have received ≥ 1 prior platinum-based cytotoxic chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound
Initial treatment may have included any of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Clinically significant cardiac disease (New York Heart Association class III or IV cardiac disease) including any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Chronic oral steroids at an equivalent dose of prednisone 5 mg daily
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1240 | |
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center 614-293-4976 osu@emergingmed.com |
Study Chair: | David E. Cohn, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000584038, OSU-07022, 2007 C0028 |
Study First Received: | January 19, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00602277 |
Health Authority: | Unspecified |
fallopian tube cancer recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Fallopian Tube Neoplasms Dental Caries |
Recurrence Fallopian Tube Diseases Carcinoma Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |