Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00072345

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.

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

Condition or Disease	Intervention/Treatment	Phase
Intraocular Melanoma Melanoma (Skin)	Drug: lomustine Drug: temozolomide Drug: thalidomide	Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.

Secondary

Determine the toxicity profile of this regimen in these patients.
Determine the duration of response and overall survival of patients treated with this regimen.

OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Aug 1, 2004

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 metastatic malignant melanoma
Unresectable stage III OR stage IV disease
Ocular, mucosal, and cutaneous melanoma allowed
Measurable disease
Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies
No more than 2 symptomatic hemorrhagic lesions in the brain
No hemorrhagic lesion(s) greater than 1 cm in diameter

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 80-100%

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT and SGPT no greater than 2 times ULN
Alkaline phosphatase no greater than 2 times ULN
Lactic dehydrogenase no greater than 2 times ULN

Renal

Creatinine no greater than 2 mg/dL

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 congestive heart failure
No ventricular arrhythmia
No uncontrolled arrhythmia

Gastrointestinal

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

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
HIV negative
No AIDS-related illness
No serious infection requiring IV antibiotics
No other uncontrolled medical illness that would preclude study participation
No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:
Detected incidentally at transurethral resection of the prostate (TURP)
Comprises less than 5% of resected tissue
Prostate-specific antigen normal since TURP