A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
Inclusion Criteria
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior immunotherapy or biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior systemic chemotherapy for melanoma
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior focused radiotherapy for brain metastases
- At least 3 weeks since prior radiosurgery
- At least 4 weeks since prior whole brain radiotherapy
- At least 3 weeks since prior interstitial brachytherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- At least 3 weeks since prior surgery for brain metastases
- At least 3 weeks since prior surgery requiring general anesthesia
Other
- Recovered from all prior therapies
