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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncolytics Biotech
• Collaborator: University of Texas
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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.