Randomized Phase II Neoadjuvant Study of Temozolomide Alone or With Pegylated Interferon-alpha 2b in Patients With Resectable AJCC Stage IIIB/IIIC or Stage IV (M1a) Metastatic Melanoma
Temozolomide is a drug that is designed to work by stopping cancer cells from making new
DNA. If they cannot make DNA, they can't split into 2 new cancer cells.
Pegylated Interferon alpha-2b is a protein made by the human immune system that helps to
fight viral infections and regulate cell function.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of two treatment groups (Arm A or Arm B). You have an
equal chance of being assigned to either group and getting the treatment assigned to that
group. You will not know which group you are assigned to.
Arm A: Participants in this group will take temozolomide once a day for 7 days in a row.
This will be followed by 7 days without any treatment. This will be repeated 3 more
times(for a total of 8 weeks - 1 cycle) before you have routine surgery.
Arm B: Participants in this group will take temozolomide on the same schedule as those in
Arm A. However, participants in this group will also receive pegylated interferon alpha-2b
as an injection under the skin once a week for a total of 8 weeks before they have routine
surgery. Tylenol will be given to participants in this group before their pegylated
interferon alpha-2b injection. After the first injection, they will also need to stay in
the clinic for 2 hours of observation.
Your body weight will be used when calculating the dosage of Temozolomide.
You will have blood (about 1 tablespoon each time) drawn at 2 times, to check your response
to treatment. The first sample will be drawn before you start treatment. The second sample
will be drawn around Day 57 of treatment.
On Days 15, 29, 43, and 57 of treatment, you will be asked about any illness you have
experienced and any medications you may be taking. You will have a physical exam, including
measurement of vital signs. You will have tumor measurements and a performance status
evaluation. You will also have about 1 tablespoon of blood drawn for routine tests at each
visit . Any side effects you may have experienced will also be recorded.
All participants will receive 1 cycle (8 weeks) of treatment followed by surgery to remove
the tumor. The size of the tumor will be closely monitored during study treatment. If the
tumor increases in size by 50% (half) or greater, study treatment will be stopped and you
will immediately have surgery. If you have to stop treatment due to side effects from the
drug(s), you may be able to start up again once the side effect has gone away or decreased
in severity enough. However, the time you are off therapy will count towards the total 8
weeks that you can receive treatment. If recovery from the side effect requires a total of 8
weeks or more from the start of treatment, you will be removed from the study and receive
surgery. Tumor and blood samples will be collected during surgery to check how the disease
is responding to treatment.
Your routine surgery will be scheduled to take place up to 90 days following completion of
your treatment and as soon as your blood counts have recovered to the normal level.
After surgery, if you are experiencing side effects from the study drugs, but show stable
disease or you are responding to treatment, you will be able to receive 3 additional cycles
of therapy (24 weeks). You will have a physical exam, including measurement of vital signs
and routine blood tests (about 1 tablespoon) every 4 weeks. You will then be followed every
3 months with routine blood tests (about 1 tablespoon each time) for the first 3 years, and
every 6 months up to 8 years. After that, follow-up will be at the discretion of your
primary physician. CT scans of your chest, abdomen, and pelvis will be performed after each
cycle of therapy for the 3 additional cycles, then every 6 months up to 5 years and then, at
the discretion of your primary physician.
This is an investigational study. Temozolomide alone and given with pegylated interferon
alpha-2b is authorized for use in research only. Neither of these drugs is currently
approved by the FDA for this treatment. About 124 patients will be enrolled on this study.
All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Pathological Response CR+PR
Evaluated after a total of 8 weeks of therapy before definitive surgery.
Wen-Jen Hwu, MD PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|