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A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

Thank you

Trial Information

A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma


OBJECTIVES:

- Determine the response rate in patients with advanced melanoma treated with
temozolomide and pegylated interferon alfa.

- Determine the toxicity profile of this regimen in these patients.

- Determine the duration of disease response and overall survival of patients treated
with this regimen.

OUTLINE: Patients are stratified according to CNS metastases (yes vs no).

Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa
subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of
disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with
CNS metastases) will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant melanoma

- Unresectable stage III or stage IV disease

- Ocular, mucosal, or cutaneous melanoma

- Measurable disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 3 times ULN

- Alkaline phosphatase no greater than 3 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No history of severe cardiovascular disease

- No myocardial infarction within the past 6 months

- No unstable angina

- No New York Heart Association class III or IV heart disease (congestive heart
failure)

- No ventricular tachyarrhythmias

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No AIDS-related illness

- No frequent vomiting or other medical condition that would preclude oral medication
intake (e.g., partial bowel obstruction)

- No serious infection requiring IV antibiotics

- No psychiatric disorder requiring ongoing therapy or medication

- No nonmalignant illness or other medical condition that would preclude study

- No other active malignancy within the past 2 years except non-melanoma skin cancer,
carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially
during transurethral resection of the prostate (TURP) (comprising less than 5% of
resected tissue) with PSA level normal since TURP

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy or immunotherapy and recovered

- No concurrent immunotherapy

Chemotherapy:

- No prior dacarbazine

- No prior temozolomide

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids

Radiotherapy:

- At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or
radiosurgery

- At least 3 weeks since prior radiotherapy to the brain for brain metastases

- Prior radiotherapy to indicator lesions allowed if there is evidence of disease
progression

- Recovered from prior radiotherapy

- No concurrent radiotherapy

Surgery:

- At least 2 weeks since prior surgical procedure requiring general anesthesia and
recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Wen-Jen Hwu, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-005

NCT ID:

NCT00027742

Start Date:

May 2001

Completion Date:

June 2005

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • iris melanoma
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021