Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00027742

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Melanoma Melanoma (Skin)	Biological: pegylated interferon alfa Drug: temozolomide	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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