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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984464
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : April 10, 2015
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech

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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: REOLYSIN Drug: Carboplatin Drug: Paclitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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®

Primary Outcome Measures :
  1. 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 Measures :
  1. Evaluate the safety and tolerability of the treatment regimen in the study population. [ Time Frame: Within 30 days of last dose of REOLYSIN ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984464

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United States, Texas
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Oncolytics Biotech
University of Texas
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Principal Investigator: Devalingam Mahalingam, MD, PhD Cancer Therapy & Research Center at UTHSCSA

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Responsible Party: Oncolytics Biotech Identifier: NCT00984464    
Other Study ID Numbers: REO 020
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Oncolytics Biotech:
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action