A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
Collecte de données
Mélanome+8
+ Néoplasmes germinaux et embryonnaires
+ Néoplasmes par type histologique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
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