A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: July 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location