High-dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI
The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 (Antigen-Specific Cancer Immunotherapeutic, ASCI), can help to control unresectable or metastatic melanoma in patients expressing MAGE-A3 antigen in tumor cells. The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective Response Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
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.
The Study Drugs:
HDIL-2 is similar to a hormone naturally found in the body that boosts the immune system by helping "natural killer" (NK) cells live longer and work better. NK cells are a type of white blood cell that kill other cells, and they may kill cancer cells.
recMAGE-A3 + AS15 ASCI is a vaccine designed to teach your immune system to recognize molecules expressed on the tumor cells and to kill those tumor cells. This may increase the effectiveness of IL-2 by slowing the growth of the cancer cells, which may cause them to die.
Study Drug Administration:
Eligible participants will begin the study within 14 days of signing the consent form. All participants will be seen in clinic on Day 1 of weeks 1,3,5,7 while receiving cycles 1 and 2 of HDIL-2, Day 1 of weeks 9,11,15 while receiving cycles 3 and 4, Day 1 on weeks 18,21,24 while receiving cycles 5 and 6, and Day 1 of weeks 27,30 while receiving cycles 7 and 8 (Figure 1 and 2). Patients will receive recMAGE-A3 + AS15 in clinic on the same days stated above. After the injection on Day 1 of weeks 1, 3, 9, 11, 18, 21, 27, 30, participants will be admitted to the hospital to receive HDIL-2. Treatment of HDIL-2 will start on Day 2 and within 24 hours of receiving recMAGE + AS15.
Participant may continue to receive the study drug combination for up to 8 cycles (33 weeks) and ASCI alone for up to 76 more weeks. Participants continuing on the study beyond completing 8 cycles of HDIL-2 will receive the ASCI injection (recMAGE-A3 + AS15) on Day 1 every 6 weeks for 4 doses (weeks 34,40,46,52) then on Day 1 every 12 weeks (weeks 64, 76, 98, 110) for 4 doses. Participants who had their HDIL-2 discontinued before completing 8 cycles because of HDIL-2 related toxicities without showing signs of progression of disease or those who had their HDIL-2 discontinued before completing 8 cycles because of achieving complete response will be allowed to continue on the ASCI injection alone. Participant will be taken off the study therapy early if the disease gets worse, they experience intolerable side effects, or the study doctor thinks it is in the participant's best interest.
This is an investigational study. IL-2 is commercially available and FDA approved for the treatment of metastatic melanoma. HDIL-2 is a higher dose than the standard approved dose of IL-2. RecMAGE-A3 + AS15 is not FDA approved or commercially available yet. It is currently being used for research purposes only.
|Contact: Wen-Jen Hwu, MD, PHD||713-792-2921|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Wen-Jen Hwu, MD,PHD||UT MD Anderson Cancer Center|