Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma
THE STUDY DRUGS:
Decitabine is designed to slow tumor growth and may cause death of cancer cells.
Interferon alfa-2B is designed to activate your immune system, which may help keep tumors
from growing, and may shrink tumors.
STUDY TREATMENT:
If you are found to be eligible to take part in this study, you will receive decitabine by
vein over 1 hour on Days 1-5 of each cycle. A cycle in this study is 28 days long. All
treatments with decitabine will take place at M. D. Anderson.
Once you have completed 2 cycles of decitabine (on Day 1 of Cycle 3), you will begin taking
interferon alfa-2b twice each day (morning and afternoon) while continuing the same 5-day
dosing schedule for decitabine. Interferon alfa-2b will be given as a subcutaneous (just
under the skin) injection. It can be given by yourself or a caregiver at home or by your
local doctor. You and your caregiver will be taught how to do the injection.
STUDY VISITS:
You will have the following tests/procedures performed during clinic visits.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any medications or treatments you may be currently receiving.
- You will have a performance status evaluation.
- You will be asked about any side effects you may have experienced since your last
visit. You will have blood drawn (about 1 teaspoon) for routine testing.
Beginning in Cycle 3, you will be required to return to the clinic around Day 14 of each
cycle to have the following tests:
- You will have blood drawn (about 1 teaspoon each time) once a week for routine tests.
If you do not experience severe side effects during Cycles 3 and 4, you will no longer
be required to have weekly routine blood testing. Instead, you will return to have
routine blood drawn on Day 1 of each cycle. This once-weekly schedule will restart if
you experience severe side effects in Cycle 5.
- You will have a CT or MRI scan to check the status of the disease.
- Your vital signs will be measured
- You will be asked about any side effects you may have experienced since your last
visit.
LENGTH OF STUDY:
You will continue taking the study drug combination unless the disease gets worse, you
develop an illness that does not allow you to continue receiving the study therapy, or you
experience any intolerable side effects. If any of these things occur, you will be removed
from this study.
This is an investigational study. Decitabine is FDA approved and commercially available for
the treatment of myelodysplastic syndrome (MDS). Interferon alfa-2b is FDA approved and
commercially available for the treatment of several types of cancer, such as malignant
melanoma, hairy cell leukemia, and non-Hodgkin's lymphoma. Their use together in this study
in the treatment of PRC is investigational and authorized for use in research only.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS) Times
Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.
From treatment start or until disease progression or death for any reason, at least 16 weeks
No
Ana M. Aparicio, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2006-0962
NCT00561912
October 2007
November 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |