Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Oncolytics Biotech
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech
ClinicalTrials.gov Identifier:
NCT00984464
First received: September 24, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma
 Biological: REOLYSIN
Drug: Carboplatin
Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Oncolytics Biotech:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of the treatment regimen in the study population. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: September 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: REOLYSIN
    3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1,2,3,4 and 5 of a 21-day cycle
    Drug: Carboplatin
    6 AUC mg/ml min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
    Other Name: Paraplatin®
    Drug: Paclitaxel
    200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
    Other Name: Taxol®
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984464

Locations
United States, Texas
Cancer Therapy & Research Center at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact: Devalingam Mahalingam, MD, PhD     210-413-1723     Mahalingam@uthscsa.edu    
Principal Investigator: Devalingam Mahalingam, MD, PhD            
Sponsors and Collaborators
Oncolytics Biotech
University of Texas
Investigators
Principal Investigator: Devalingam Mahalingam, MD, PhD Cancer Therapy & Research Center at UTHSCSA
  More Information

No publications provided

Responsible Party: Oncolytics Biotech
ClinicalTrials.gov Identifier: NCT00984464     History of Changes
Other Study ID Numbers: REO 020
Study First Received: September 24, 2009
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Oncolytics Biotech:
metastatic
melanoma
REOLYSIN
 chemotherapy
carboplatin
paclitaxel

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carboplatin
 Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013