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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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

1. Histologically documented diagnosis of melanoma metastases.

2. Stage IIIB/IIIC (N2b, N2c and N3) or stage IV (M1a) melanoma patients with measurable
and potentially resectable metastases without clinical and radiological evidence of
other distant metastases.

3. An ECOG performance status of 0-1.

4. Age 18 or older.

5. Adequate organ function defined as follows: a.) Absolute granulocytes greater than or
equal to 1,000/mm^3 and Platelets greater than or equal to 100,000/mm^3, b.) Serum
bilirubin and serum creatinine of less than or equal to 1.5 times upper limit of
laboratory normal. If serum creatinine is greater than 1.5 times upper limit of
laboratory normal, the urine creatinine clearance must be greater than 60 ml/min.,
c.) SGOT (AST), SGPT (ALT) and alkaline phosphatase less than or equal to 3 times
upper limit of laboratory normal.

6. Patients have not had any previous systemic chemotherapy for metastatic melanoma.
Prior biologic therapy, targeted therapy or immunotherapy are allowable, but must be
at least 2 weeks since prior therapy before starting study drugs. No other concurrent
chemotherapy, immunotherapy, or radiotherapy.

7. Prior radiation therapy used to enhance local regional control is permitted, but must
be at least 2 weeks since prior therapy before starting study drugs. In addition, the
patient must have unirradiated metastatic sites for response evaluation and has fully
recovered from its toxicity. Lesions within the prior field of radiation may only be
used as indicator lesions if there has been recent evidence of disease progression
after .

8. Ability to understand and sign an informed consent form, indicating awareness of the
investigational nature of this study.

Exclusion Criteria:

1. Significant cardiac or pulmonary dysfunction, such as a history of severe
cardiovascular disease, myocardial infarction within 6 months of the start of
treatment, unstable angina, Class III or Class IV congestive heart failure,
ventricular arrhythmia, or any uncontrolled arrhythmia.

2. Current significant psychiatric illness.

3. Serious infection requiring intravenous antibiotics, or any non-malignant medical
illnesses that are uncontrolled or whose control may be jeopardized by complications
of this therapy.

4. Frequent vomiting or any medical condition (e.g. partial bowel obstruction) that
could interfere with oral medication intake.

5. Autoimmune or immunosuppressive disorders (e.g. HIV or AIDS-related illness).

6. Patients who require therapy with systemic corticosteroids.

7. No evidence of active secondary malignancy that requires chemotherapy within the past
2 years (excluding non-melanoma skin cancer, and/or all carcinoma in-situ)

8. Pregnant or lactating women are ineligible. Women of childbearing potential must have
a negative urine pregnancy test within a week of initiation of therapy. All patients
must agree to use medically approved contraceptive measures to prevent pregnancy
during treatment.

9. Any other medical condition or reason that, in the principal investigator's opinion,
makes the patient unsuitable to participate in a clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Pathological Response CR+PR

Outcome Time Frame:

Evaluated after a total of 8 weeks of therapy before definitive surgery.

Safety Issue:


Principal Investigator

Wen-Jen Hwu, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • Temozolomide
  • Temodar
  • Pegylated Interferon Alpha-2b
  • PEG-Intron
  • PGI
  • Resectable metastatic melanoma
  • Surgery
  • Melanoma



UT MD Anderson Cancer Center Houston, Texas  77030