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

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ClinicalTrials.gov Identifier: NCT00984464
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : April 10, 2015
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date April 10, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00984464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
  • Evaluate the safety and tolerability of the treatment regimen in the study population. [ Time Frame: 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 [ Time Frame: until death ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
Official Title  ICMJE A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • 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®
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
43
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984464
Other Study ID Numbers  ICMJE REO 020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oncolytics Biotech
Study Sponsor  ICMJE Oncolytics Biotech
Collaborators  ICMJE University of Texas
Investigators  ICMJE
Principal Investigator: Devalingam Mahalingam, MD, PhD Cancer Therapy & Research Center at UTHSCSA
PRS Account Oncolytics Biotech
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP