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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Biological: REOLYSIN Drug: Carboplatin Drug: Paclitaxel||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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 cycleOther Name: Paraplatin®
- Drug: Paclitaxel
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycleOther Name: Taxol®
- 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. ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00984464
|United States, Texas|
|Cancer Therapy & Research Center at UTHSCSA|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Devalingam Mahalingam, MD, PhD||Cancer Therapy & Research Center at UTHSCSA|