Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ABI-007 by vein
over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months
that you receive ABI-007, you will also receive ipilimumab. You will receive ipilimumab by
vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart.
You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.
Every week, blood (about 1 teaspoon) will be drawn for routine tests.
Before each cycle of ABI-007:
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn for tests of the immune system (first 3 cycles
- You will be asked about any other drugs you may be taking and about any side effects
you may be having.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed
to check the status of the disease.
Length of Study:
You may receive ipilimumab for up to 3 months. You may continue taking ABI-007 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 or intolerable side effects occur.
If you stop receiving the study drugs for any reason, you will have an End-of-Treatment
Within 14 days after you stop study treatment, you will come into the clinic for the
End-of-Treatment Visit. At this visit, the following tests will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any other drugs you may be taking and any side effects you may
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If the study doctor thinks it is in your best interest, you will have a CT scan or MRI
scan to check for side effects.
Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be
contacted by telephone or during a routine clinic visit to see how you are doing. If you
are called, each call should last about 5 minutes.
This is an investigational study. Ipilimumab is FDA approved and commercially available
for the treatment of metastatic melanoma. ABI-007 is FDA approved and commercially
available for the treatment of metastatic breast cancer. It is investigational to use
ABI-007, either alone or in combination with ipilimumab, for the treatment of metastatic
Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Primary efficacy endpoint is rate of progression-free survival (PFS) at 6 months. At end of the study, if there are more than 14 patients who are alive and progression free at 6 months among the 64 patients, the ABI-007 plus Ipilimumab combination will be considered successful and will be considered for further study. Simon's minimax two-stage design used to perform interim efficacy monitoring.
Agop Y. Bedikian, MD,BS
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|