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

NCT00984464 | Completed Phase 2

• 1 other identifier: REO 020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Keywords

metastatic; melanoma; REOLYSIN; chemotherapy; carboplatin; paclitaxel

Outcome Measures

Primary Outcomes (1)

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

  must be confirmed 4 weeks after the criteria for response are first met.

Secondary Outcomes (2)

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

  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

  until death

Interventions

REOLYSIN BIOLOGICAL

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

Carboplatin DRUG

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

Also known as: Paraplatin®

Paclitaxel DRUG

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

Also known as: Taxol®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncolytics Biotech: lead
• University of Texas: collaborator

Study Sites (1)

Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

reolysin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Devalingam Mahalingam, MD, PhD

  Cancer Therapy & Research Center at UTHSCSA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)