Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

April 8, 2015 updated by: Oncolytics Biotech

A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and safe in the treatment of metastatic melanoma.

Study Overview

Status

Completed

Conditions

Metastatic Melanoma

Intervention / Treatment

Detailed Description

Cutaneous melanoma is one of the most rapidly increasing cancers in the US and around the world with an increase in incidence of about 3-7% per year for fair-skinned Caucasian populations. An estimated 62,480 cases of invasive melanoma will be diagnosed in the US in 2008 with an estimated 8,420 deaths. An additional 46,170 cases of melanoma in situ are predicted.

Melanoma that has spread to distant sites (stage IV) is rarely curable.

This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with metastatic melanoma.

Response is a primary endpoint of this trial.

Patients may continue to receive chemotherapy in combination with REOLYSIN for up to 8 cycles and may continue indefinitely on REOLYSIN monotherapy under this protocol, provided they have not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - San Antonio, Texas, United States, 78229
    - Cancer Therapy & Research Center at UTHSCSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

have histologically or cytologically confirmed metastatic malignant melanoma.
have measurable disease.
have failed at least one prior treatment for metastatic disease or not considered a candidate for standard first line treatment.
have not received previous carboplatin and/or paclitaxel chemotherapy.
have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
any surgery involving the melanoma (except biopsies) must have occurred at least 28 days prior to study enrolment.
be at least 18 years of age.
have received NO chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days prior to receiving study drug
have ECOG Performance Score of ≤ 2.
have a life expectancy of at least 3 months.
absolute neutrophil ≥ 1.5 x 10^9; Platelets ≥ 100 x10^9; Hemoglobin ≥ 9.0 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN.
negative pregnancy test for females with childbearing potential.
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.

Exclusion Criteria:

receive concurrent therapy with any other investigational anticancer agent while on study.
be good candidate for surgery with curative intent for metastatic disease.
have a history of or current evidence of brain metastasis(es).
be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
be a pregnant or breast-feeding woman.
have clinically significant cardiac disease.
have dementia or altered mental status that would prohibit informed consent.
have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment) Time Frame: must be confirmed 4 weeks after the criteria for response are first met.	must be confirmed 4 weeks after the criteria for response are first met.

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the safety and tolerability of the treatment regimen in the study population. Time Frame: Within 30 days of last dose of REOLYSIN	Within 30 days of last dose of REOLYSIN
Assess progression-free survival (PFS) and overall survival (OS) and disease control [CR+PR+Stable Disease (SD)] rate and duration in the study population Time Frame: until death	until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncolytics Biotech

Collaborators

University of Texas

Investigators

Principal Investigator: Devalingam Mahalingam, MD, PhD, Cancer Therapy & Research Center at UTHSCSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria