An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected, Intermediate-Thickness, Node-Negative Melanoma
The Study Drugs:
Pegylated Interferon alfa-2b is a protein made by the human immune system that helps to
fight viral infections and regulate cell function.
Gp100 is a protein that is found on melanoma cells. In laboratory studies, the gp100 vaccine
has been shown to stimulate the immune system to "recognize" and kill melanoma cells that
have gp100 on their cell surfaces.
Evaluation of Immune cell response to vaccine:
Blood (about 3-1/2 tablespoons) will be drawn on Weeks 4, 7,10,13,16,19, and 22 for tests
to check the response of your immune system to the vaccine, before each injection.
Parts of the Study:
There are 2 parts to this study, an Induction Phase and a Maintenance Phase. The Induction
Phase treatment is the first course of treatment used to stimulate ("turn on") an
immune-cell response to fight cancer and to learn the body's response to the treatment. The
Maintenance Phase treatment is continued therapy and is used to maintain the immune-cell
response and to help keep the disease in remission.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to 1 of 3 treatment groups. You will have an equal chance of being
assigned to one of each of the groups. Participants in each group will receive the same dose
levels of pegylated Interferon alfa-2b and gp100. The difference between each group will be
the dosing schedule of pegylated Interferon alfa-2b.
You will give yourself the pegylated Interferon alfa-2b at home, and the gp100 will be given
to you by the research nurse in the clinic. You will be shown how to give yourself Pegylated
Interferon alfa-2b at home.
Pegylated Interferon alfa-2b will be given immediately after the GP-100 Peptide Vaccine
injection.
Participants in Group 1 will take pegylated Interferon alfa-2b at a certain dose level once
a week for 4 weeks (in the Induction Phase), followed by once a week for 20 weeks in the
Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).
Participants in Group 2 will take pegylated Interferon alfa-2b at a certain dose level once
a week for 8 weeks (in the Induction Phase), followed by once a week for 16 weeks in the
Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).
Participants in Group 3 will take pegylated Interferon alfa-2b at a certain dose level once
a week for 12 weeks (in the Induction Phase), followed by once a week for 12 weeks in the
Maintenance Phase (when the drug will be taken at a lower dose level than during Induction).
Study Treatment:
You will take pegylated Interferon alfa-2b as an injection just under your skin. You will
receive gp100 as an injection just under your skin once every 3 weeks.
On Week 1, PEG-Intron will be given right after GP-100 Peptide Vaccine injection in the
clinic. You will be observed for at least 30 minutes after both GP-100 Peptide Vaccine and
PEG-Intron Injections.
On Weeks 4, 7, 10, 13, 16, 19, and 22 (+/- 1 day, not counting institutional holidays),
GP-100 peptide will be given in the clinic. You will be observed for at least 30 minutes
after GP-100 Peptide Vaccine injection. You should give the PEG-Intron to yourself on the
same day of GP-100 Peptide Vaccine injection. The injection of gp100 will be given in two
separate areas of your limbs, such as in an upper arm or thigh. It will be given in the same
area each time.
Length of Study:
You will remain on this study for up to 25 weeks, unless the disease comes out of remission
or you experience intolerable side effects.
End-of-Treatment Visit:
At the end of study treatment (approximately 3 weeks after the last injection of gp100), you
will have the following tests:
- You will have a review of your general health and any medical problems you may be
having.
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have the leukapheresis repeated.
- You will have a CT scan of chest, stomach, and pelvis, and you will have an MRI or CT
scan of the brain.
While you are on this study no steroids will be allowed while on treatment.
This is an investigational study. Pegylated Interferon alfa-2b is FDA approved and
commercially available for the treatment of chronic hepatitis C. Gp100 is not FDA approved
or commercially available. At this time, the combination use of pegylated Interferon alfa-2b
plus gp100 is being used for research purposes only in this study.
Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Maximum T-cell Levels During 24-Week Treatment
Patient's T-cell levels assessed every 3 weeks using a tetramer assay.
No
Wen-Jen Hwu, MD, PhD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2006-0816
NCT00861406
March 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |