IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 6 groups of 3 participants will be enrolled
in the Phase I portion of the study, and up to 46 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of ipilimumab you receive will depend
on when you joined this study. The first group of participants will receive the lowest dose
level of ipilimumab. Each new group will receive a higher dose of ipilimumab than the group
before it, if no intolerable side effects were seen. This will continue until the highest
tolerable dose of ipilimumab is found.
If you are enrolled in the Phase II portion, you will receive ipilimumab at the highest dose
that was tolerated in the Phase I portion.
All participants will receive the same dose level of cisplatin, temozolomide, interferon
alfa-2b, and IL-2.
Catheter:
If you are found to be eligible to take part in this study, you will have a central venous
catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube
that will be placed into a large vein while you are under local anesthesia. Your doctor
will explain this procedure to you in more detail, and you will be required to sign a
separate consent form.
Study Drug Administration:
The study drugs will be given in 3 stages: induction, consolidation, and maintenance.
Induction:
Induction will last 12 weeks. You will receive the study drugs in up to four 3-week cycles:
- You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle.
- You will take temozolomide by mouth 1 time a day on Days 2-5 of each cycle. You should
take temozolomide on an empty stomach at least 2 hours before or after a meal. Do not
open the capsule, mix it with food, or chew it.
- You will receive cisplatin by vein over 1 hour on Days 2-4 of each cycle.
- You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each
cycle.
- You will receive interferon alfa-2b as an injection under your skin on Days 2-6 of each
cycle.
Consolidation:
Consolidation will last 12 weeks. You will receive the study drugs in three 4-week cycles.
- You will receive ipilimumab by vein over 90 minutes on Day 1 of consolidation.
- You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each
cycle.
- You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each
cycle.
Maintenance:
Maintenance will last about 1½ years. You will receive ipilimumab by vein over 90 minutes
on Day 1 of up to six 12-week cycles.
Other Drugs:
You will be given other drugs to help decrease the risk of side effects. The study staff
will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
Before each cycle (+/- 3 days):
- You will be asked about any drugs you may be taking and any side effects you may have
had.
- Your performance status will be recorded.
- Your vital signs will be measured.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
Every week, blood (about 1 teaspoon) will be drawn for routine tests. Before each cycle,
some of this blood will be used to check your liver and kidney function.
At the end of each cycle, you will have a physical exam, including measurement of your
weight. Any tumor that can be felt with the hands will be measured during the physical exam
to see if it has changed size.
Every 2 cycles (+/- 7 days), you will have a chest x-ray and CT or MRI scans to check the
status of the disease.
Anytime the doctor thinks it is needed, photos of the skin lesions will be taken. Your
private areas will be covered (as much as possible), and a picture of your face will not be
taken unless there are lesions on your face.
Length of Study:
You may continue taking the study drugs for up to 2 years. 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.
Your participation on the study will be over once you have completed the end-of-treatment
visit and follow-up.
End-of-Treatment Visit:
Within 14 days after you stop the study therapy, the following tests and procedures will be
performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may have
had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a CT or MRI scan.
Follow-Up:
Every 2 months for up to 3 years, you will be contacted by phone or during a clinic visit to
see how you are doing.
This is an investigational study. Temozolomide, cisplatin, ipilimumab, interferon alfa-2b,
and aldesleukin are FDA approved and commercially available to treat metastatic cancer.
However, it is investigational to give temozolomide to patients with metastatic melanoma.
Up to 64 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
Tumor Response by Participant using immune-related response criteria (irRC)
Tumor assessments using irRC modified World Health Organizations (WHO) criteria: Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions. Immune-Related Partial Response (irPR): decrease of 50% or greater. Immune-Related Progressive Disease (irPD): At least 25% increase in sum of products of all index lesions over baseline sum of products of diameters (SPD) calculated for index lesions. Assessment include photographic measurement of skin lesions, computed tomography scans and/or magnetic resonance imaging tumor assessments until documented tumor progression.
End of 2 cycles, 24 weeks
No
Agop Y. Bedikian, MD,BS
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0073
NCT01409174
February 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |