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

Primary Purpose

Metastatic Melanoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

REOLYSIN

Carboplatin

Paclitaxel

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring metastatic, melanoma, REOLYSIN, chemotherapy, carboplatin, paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Therapy & Research Center at UTHSCSA

Outcomes

Primary Outcome Measures

Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment)

Secondary Outcome Measures

Evaluate the safety and tolerability of the treatment regimen in the study population.

Assess progression-free survival (PFS) and overall survival (OS) and disease control [CR+PR+Stable Disease (SD)] rate and duration in the study population

Full Information

NCT ID

NCT00984464

First Posted

September 24, 2009

Last Updated

April 8, 2015

Sponsor

Oncolytics Biotech

Collaborators

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00984464

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oncolytics Biotech

Collaborators

University of Texas

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Melanoma

Keywords

metastatic, melanoma, REOLYSIN, chemotherapy, carboplatin, paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

REOLYSIN

Intervention Description

3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1,2,3,4 and 5 of a 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin®

Intervention Description

6 AUC mg/ml min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol®

Intervention Description

200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Evaluate the safety and tolerability of the treatment regimen in the study population.

Time Frame

Within 30 days of last dose of REOLYSIN

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Devalingam Mahalingam, MD, PhD

Organizational Affiliation

Cancer Therapy & Research Center at UTHSCSA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Therapy & Research Center at UTHSCSA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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