High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI
|ClinicalTrials.gov Identifier: NCT01266603|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: HDIL-2 Biological: recMAGE-A3 + AS15||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of High Dose Interleukin-2 (HDIL-2) With Recombinant MAGE-A3 Protein Combined With Adjuvant System AS15 (recMAGE-A3 + AS15) in Patients With Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: HDIL-2 + recMAGE-A3 + AS15
HDIL-2 720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle. recMAGE-A3 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2.
720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle.
Other Names:Biological: recMAGE-A3 + AS15
300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2.
- Objective Response Rate [ Time Frame: 8 weeks ]Objective response is either a complete response or a partial response measured at week 8. Tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST) solid tumor response criteria by MR or CT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266603
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wen-Jen Hwu, MD,PHD||M.D. Anderson Cancer Center|