Isolated Limb Infusion Chemotherapy With Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma
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|ClinicalTrials.gov Identifier: NCT01531244|
Recruitment Status : Withdrawn
First Posted : February 10, 2012
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: dactinomycin Drug: melphalan Biological: Conditionally replicative adenovirus 3/5-delta||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Isolated Limb Infusion and Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
Experimental: Treatment (targeted gene therapy and ILI)
Patients receive melphalan and dactinomycin via ILI. Patients then receive CRAd 3/5-delta via ILI.
Given via ILI
Other Name: ACT-D, actinomycin C1, actinomycin D, AD, Cosmegen, DACT
Given via ILI
Other Name: Alkeran, CB-3025, L-PAM, L-phenylalanine mustard, L-Sarcolysin, Melfalan
Biological: Conditionally replicative adenovirus 3/5-delta
Given via ILI
Other Name: CRAd 3/5-delta
- Optimal tolerated dose (OTD) of CRAd 3/5 [ Time Frame: 14 days ]Defined as the dose level at which > 50% of target lesion viral infectivity is achieved and < 2 of 6 patients have dose limiting toxicities.
- Response rate (complete response [CR] + partial response [PR]) of CRAd 3/5-delta in combination with standard M-ILI (Phase II) [ Time Frame: 3 months ]Assessed using revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
- Progression Free Survival (Phase II) [ Time Frame: 2 years ]Duration of time from start of treatment to time of progression or death, whichever occurs first.
- Safety of CRAd 3/5-delta in combination with standard M-ILI [ Time Frame: 2 years ]Descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Infectivity rate of CRAd 3/5-delta [ Time Frame: 2 days; baseline and day 1 or 2 post treatment ]Lesion biopsies; quantified using immunohistochemical staining method.
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): NCT01531244
|Principal Investigator:||Ryan Fields, M.D.||Washington University School of Medicine|