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
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.
ASCI is a immunotherapy designed to teach your immune system to fight cancer in the same way
that you are given vaccines to prevent disease by teaching your immune system to fight an
infection caused by germs. Because the cancer is made by your own body, the immune system
does not recognize the cancer cells as being harmful. Your immune system needs to be
"trained" to recognize the cancer cells. This is done by injecting a protein (the MAGE-A3
protein) that is found in the tumor and training your body to recognize it and to destroy
the cells that have this protein. 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:
If you are found to be eligible to take part in this study, you will begin the study drugs
within 14 days of signing the second consent form. To receive the study drugs, you will be
admitted to the hospital, either in the intensive care unit (ICU) or a specifically
designated nursing unit where study drugs can be administered, on Day 2 of each cycle and
may remain in the hospital for up to 7 days each cycle.
You may receive a total of 24 ASCI doses either in combination with HDIL-2 or alone. You
may receive the study drugs in combination for up to 30 weeks. After that, you may receive
the ASCI study medication alone for up to 176 more weeks.
Cycle 1 is 14 days (Weeks 1 and 2):
- On Day 1 of Cycle 1, you will receive the ASCI study medication as an injection. Each
injection will be given in the muscle of your upper arm or in your thigh. You will be
watched in the clinic for at least 30 minutes after each injection.
- On Day 2 (+/- 2 business days), you will receive HDIL-2 through a catheter (a small
plastic tube that is put into your vein under your collar bone or in your arm) over 15
minutes. HDIL-2 treatment will be delayed in cycles 2, 3, 4, 5, 6, 7, or 8 until all
HDIL-2 related side effects either go away or the study doctor thinks they are under
control.
Cycle 2 is 42 days (Weeks 3-8):
- On Day 1 of Weeks 3, 5, and 7 (+/- 2 business days) , you will receive the ASCI study
medication as an injection.
- On Day 2 of Week 3 (+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 3 is 14 days (Weeks 9 and 10):
- On Day 1 of Week 9 (+/- 2 business days), you will receive the ASCI study medication as
an injection.
- On Day 2 of Week 9 (+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 4 is 49 days (Weeks 11-17):
- On Day 1 of Weeks 11 and 15 (+/- 2 business days), you will receive the ASCI study
medication as an injection.
- On Day 2 of Week 11 (+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 5 is 21 days (Weeks 18-20):
- On Day 1 of Week 18 (+/- 2 business days), you will receive the ASCI study medication
an injection.
- On Day 2 of Week 18 (+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 6 is 42 days (Weeks 21-26):
- On Day 1 of Weeks 18, 21, and 24 (+/- 2 business days), you will receive the ASCI study
medication as an injection.
- On Day 2 of Weeks 18 and 21 (+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 7 is 21 days (Weeks 27-29):
- On Day 1 of Week 27 (+/- 2 business days), you will receive the ASCI study medication
as an injection.
- On Day 2 of Week 27(+/- 2 business days), you will receive HDIL-2 by vein.
Cycle 8 is 28 days (Weeks 30-33):
- On Day 1 of Week 30 (+/- 2 business days), you will receive the ASCI study medication
as an injection.
- On Day 2 of Week 30 (+/- 2 business days), you will receive HDIL-2 by vein.
On Day 1 of Weeks 34, 40, 46, 52, 64, 76, 88, and 100 (+/- 2 business days), you will
receive the ASCI study medication as an injection.
Study Visits:
On Day 1 of Weeks 1, 3, 5, 7, 9, 11, 15, 18, 21, 24, 27, and 30 (+/- 2 business days):
- You will have a physical exam, including measurement of your weight and vital signs.
Blood (about 2 tablespoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having and drugs you are taking.
On Day 2 of Weeks 1, 3, 5, 7, 9, 11, 18, 21, 27, and 30 (+/- 2 business days):
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having and drugs you are taking.
During Weeks 8, 17, 26, and 33, 34, 40, 46 and 52 and every 12 weeks thereafter (+/- 7
days): (+/- 7 days):
- You will have a chest x-ray and a computed tomography (CT) scan of your chest, abdomen,
and pelvis to check the status of the disease.
- You will also have an MRI scan or CT scan of the brain to check the status of the
disease.
- You will have photographs of your lesions taken if indicated by your doctor.
On Day 1 of Weeks 34, 40, 46, 52, 64, 76, 88, and 100 (+/- 2 business days):
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having and drugs you are taking.
- You will have a chest x-ray and a CT scan of your chest, abdomen, and pelvis to check
the status of the disease.
- You will also have an MRI scan or CT scan of the brain to check the status of the
disease.
- You will have photographs of your lesions taken if indicated by your doctor.
Additional Blood Draws:
Additional blood (about 4 tablespoons each time) will be drawn for laboratory tests to look
at how the study drug combination may affect the immune system. These blood draws will be
collected on Day 1 of cycle 1 and again during cycle 1 48 hours after the last dose of
IL-2. Additional blood draws (about 4 tablespoons each time) will also Part of the blood
drawn for these tests will be sent to GSK Biologicals (or a contracted laboratory) for
testing.
Length of Study:
You may continue to receive the study drug combination for up to 8 cycles (33 weeks) and
ASCI alone for up to 76 more weeks (+/- 2 business days). If you continue beyond
completing 8 cycles of HDIL-2, you will receive the ASCI on Day 1 (+/- 2 business days)
every 6 weeks for 4 doses (weeks 34, 50, 46, and 52), then on Day 1 (+/- 2 business days)
every 12 weeks (weeks 64, 76, 98, and 110) for 4 doses, then on Day 1 (+/- 2 business days)
every 24 weeks (weeks 134, 158, 182, and 206) for 4 doses.
You will be taken off the study therapy early if the disease gets worse, you experience
intolerable side effects, or the study doctor thinks it is in your best interest. If you are
removed from the study because of intolerable side effects, you will be followed weekly by
either a phone call or clinic visit until the side effect is tolerable.
End-of-Dosing Visit:
After receiving the last dose of study drug combination, you will have an end-of-dosing
visit:
- Your medical history will be reviewed and you will be asked about any side effects you
may be having and drugs you are taking.
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 3 tablespoons) will be drawn for routine tests and ANA testing.
Follow-Up Visits:
You will have follow-up visits after your last dose of study drug, if the disease does not
get any worse. Starting after the last dose of study drug, you will have 1 visit every 3
months for the 1st year, every 4 months for the 2nd year, every 6 months for the 3rd and 4th
year, then once a year for up to 10 years (+/- 2 business days). At these visits, the
following will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- If the study doctor thinks it is needed, blood (about 2 tablespoons) will be drawn for
routine tests.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT scan of your
chest, abdomen, and pelvis, and/or MRI scan or CT scan of the brain to check the status
of the disease.
If the disease begins to get worse, information about the status of your health will be
collected every 2 months. If you are not able to come into the clinic to complete this
visit, you will be asked for this information over the phone. The phone call should last
about 10-15 minutes each time.
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. The ASCI study medication is not FDA approved or commercially available. It is
currently being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
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.
8 weeks
No
Wen-Jen Hwu, MD,PHD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2010-0113
NCT01266603
February 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |