Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy

NCT00602277 | Completed Phase 1

• 8 other identifiers: NCI-2009-00234CDR0000584038OSU-070222007C0028070227853P30CA016058U01CA076576
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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 (phase II closed as of 1/7/2011). Viral therapy may be able to kill tumor cells without damaging normal cells.

Conditions

Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerable dose of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus (phase I)

  Dose-limiting toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4

  At each dose level, assessed up to 5 dose levels

• Objective response (partial response and complete response)

  Response will be evaluated using the new international criteria proposed by RECIST Committee.

  Every 8 weeks during treatment and assessed up to 12 weeks after completion of treatment

Secondary Outcomes (1)

• Association of Ras oncogene and molecular markers with objective response

  During courses 1 and 2, and prior to course 3

Study Arms (1)

Treatment (viral therapy)

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. (phase II closed as of 1/7/2011). NOTE: \*Patients receive IP wild-type reovirus on days 2 and 3 in course 3.

Other: Laboratory Biomarker Analysis; Biological: Wild-type Reovirus

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (viral therapy)

Wild-type Reovirus BIOLOGICAL

Also known as: Reolysin

Treatment (viral therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
• 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)
• A patient receiving a second course of platinum-based chemotherapy for platinum-sensitive disease who then develops persistence or recurrence within 12 months is considered eligible for this trial
• Must have measurable disease by RECIST criteria (phase II) (phase II closed as of 1/7/2011)
• 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:
• High-dose therapy
• Consolidation therapy
• Intraperitoneal (IP) therapy
• Extended therapy administered after surgical or nonsurgical assessment
• One additional non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors) for recurrent or persistent disease allowed
• Patients may have received hormonal therapy for management of disease (e.g., SERMs, aromatase inhibitors, progestins, and GnRH agonists)
• No loculated ascites for which IP distribution of virus is not expected to be feasible
• No known brain metastases

You may not qualify if:

• Patients in whom insertion of an IP catheter is not feasible due to surgical contraindications or abdominal and pelvic adhesions
• Known HIV infection or hepatitis B or C
• Clinically significant cardiac disease (New York Heart Association class III or IV cardiac disease) including any of the following:
• Pre-existing arrhythmia
• Uncontrolled angina pectoris
• Myocardial infarction 1 year prior to study entry
• Compromised left ventricular ejection fraction ≥ grade 2 by MUGA or echocardiogram
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
• Chronic oral steroids at an equivalent dose of prednisone 5 mg daily
• Inhaled steroids allowed
• Patients on immunosuppressive therapy
• Concurrent routine prophylactic use of growth factor (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

reolysin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• David Cohn

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2008
• First Posted: January 28, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (1)