A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma
The Study Drugs:
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Peginterferon alfa-2b is designed to strengthen the immune system, which may decrease tumor
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 joined this study. Up to 6 groups of 3-6 participants will be
enrolled in the Phase I portion of the study, and up to 44 participants will be enrolled in
If you are enrolled in the Phase I portion, the dose of decitabine and peginterferon alfa-2b
you receive will depend on when you joined this study. The first group of participants will
receive the lowest dose level of the study drug combination. Each new group will receive a
higher dose level 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.
If you are enrolled in the Phase II portion, the dose of decitabine and peginterferon
alfa-2b you receive will depend on when you joined this study, as well as the research data
from the Phase I portion. You will be randomly assigned (as in the roll of dice) to receive
one of the dose levels (which may be from 1 to 6 dose levels, depending on the available
data from the Phase I portion) that have been found in the Phase I portion to have the least
side effects and to be possibly the most effective. This means you will have an equal
chance of being assigned to any of the dose levels that are being used at that time. As the
study goes on, if the research data suggests that one dose level may be better tolerated
than the others, new participants enrolling into the Phase II portion would be more likely
to be assigned to that possibly better dose level.
No matter which phase you are enrolled in, your dose of the study drugs may be lowered if
you do not tolerate the study drug combination well.
Study Drug Administration:
A "cycle" on this study is 28 days. Decitabine will be given by vein, over 1 hour, on Days
1-5 of each cycle. Peginterferon alfa-2b will be given by injection under the skin, once a
week (on Days 1, 8, 15, and 21). You will be giving peginterferon alfa-2b to yourself under
nursing supervision on the days you are receiving decitabine.
On Day 6 of each cycle, you will either receive Neulasta (pegfilgrastim) or Neupogen
(filgrastim). Pegfilgrastim or filgrastim will be injected under your skin. If you receive
pegfilgrastim, it will be injected only on Day 6 of each cycle. If you receive filgrastim,
it will be injected 1 time a day for as many days as the doctor decides is needed to raise
your white blood cell count.
On Day 1 of each cycle, the following procedures will be performed:
- 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
and any side effects you may have experienced.
- You will have a performance status evaluation.
- Blood (about 1 teaspoon) will be drawn for routine tests.
These same tests listed above will be repeated at additional visits with the research nurse
during Week 3 of Cycles 1 and 2. If you do not experience severe side effects during Cycles
1 and 2, these extra Week 3 visits with the research nurse will no longer be necessary in
later cycles. They may, however, be started again if needed.
At the end of of Cycle 3, and every odd cycle after that (Cycles 5, 7, 9, and so on), you
will have a scan performed (such as CT or MRI) to check the status of the disease.
Length of Study Participation:
You may remain on study for as long as you are benefitting. If the disease gets worse or
intolerable side effects occur, you will be taken off study early.
Once you go off study for any reason, you will have an end-of-study visit with the same
procedures performed as the Day 1 study visits. You may also have a scan performed (such as
CT or MRI) to check the status of the disease if you have not had one performed in the last
Every 3 months for about 2 years, researchers will call you to see how you are doing.
This is an investigational study. Decitabine is FDA approved and commercially available for
the treatment of myelodysplastic syndrome (MDS). Peginterferon alfa-2b is FDA approved and
commercially available for the treatment of hepatitis C. Their use together in this study
in the treatment of melanoma is considered experimental. At this time, the combination is
being used in research only.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Maximum Tolerated Dose
Continuous reassessment, toxicity dose level assessed with dose levels/28 day cycle
Wen-Jen Hwu, MD, PhD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|