A Phase I Trial of Ipilimumab (Immunotherapy) and Imatinib Mesylate (c-Kit Inhibitor) in Patients With Advanced Malignancies
Study Groups:
Dose Escalation Group:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of your study drug combination based on when you joined this study. Up to 4 dose
levels of the study drug combination will be tested. Up to 6 participants will be enrolled
at each dose level. The first group of participants will receive the lowest dose level.
Each new group will receive a higher dose than the group before it, if no intolerable side
effects were seen. This will continue until the highest tolerable dose of the study drug
combination is found.
Dose Expansion Group:
After the highest tolerable dose level of the study drug combination is found, up to 20
additional participants will be enrolled in the dose expansion group. Patients with
metastatic gastrointestinal stromal tumors (GIST), melanoma, or tumors with original tumor
biopsies testing positive for KIT mutations (a cancer biomarker) will be eligible to enroll
and will receive the highest dose of the study drug combination that was tolerated in the
dose escalation group.
Study Drug Administration:
If you are in the Dose Escalation Group, the first study cycle is 35 days. Each cycle after
that is 21 days.
If you are in the Dose Expansion Group, all study cycles are 21 days.
If you are in the Dose Escalation Group, you will start taking imatinib by mouth 1 time each
day for 14 days before you receive ipilimumab. On Day 15 of each cycle, you will receive a
single dose of ipilimumab by vein over 90 minutes. You will continue to take imatinib by
mouth 1 time each day.
If you are in the Dose Expansion Group, you will receive ipilimumab by vein over 90 minutes
on Day 15 of each cycle. You will also take imatinib by mouth 1 time each day of each
cycle.
Study Visits:
One (1) time each week during Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any drugs you may be taking and any side effects you may be
having.
- Blood (about 1 tablespoon) will be collected for routine tests.
- Urine will be collected for routine tests (only during the first week of Cycle 1).
Every 3 weeks during Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 tablespoon) and urine will be collected for routine tests.
Starting after Cycle 2:
- You will have a CT or MRI scan after every 2 cycles to check the status of the disease.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Ipilimumab is FDA approved and commercially available for
the treatment of unresectable or metastatic melanoma. Imatinib is FDA approved and
commercially available for the treatment of advanced or metastatic gastrointestinal stromal
tumor (GIST).
The combination of ipilimumab and imatinib is currently being used for research purposes
only.
Up to 96 participants 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
Maximum Tolerated Dose (MTD) of Ipilimumab and Imatinib Mesylate
Maximum tolerated dose (MTD) defined as highest dose level with less than 2 patients with dose limiting toxicity (DLT) out of at least six patients in the cohort.
56 days
Yes
David S. Hong, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0784
NCT01738139
February 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |