perifosine in treating patients with metastatic or recurrent malignant melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of perifosine in treating patients who have metastatic or recurrent malignant melanoma.

objectives: * determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma. * assess the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive oral perifosine daily on days 1-21. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients who achieve a complete response (cr) or partial response (pr) receive 2 additional courses after documentation of cr or stable pr (i.e., no further tumor shrinkage). patients are followed at 4 weeks and then every 3 months thereafter. projected accrual: a total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant melanoma * metastatic or recurrent disease deemed incurable by standard therapies * clinically and/or radiologically documented disease by at least 1 site that is unidimensionally measurable as follows: * at least 20 mm by x-ray or physical exam * at least 10 mm by spiral ct scan * at least 20 mm by non-spiral ct scan * bone lesions are not considered measurable * outside previously irradiated area unless evidence of progression or new lesions within irradiated field * no known brain metastases patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than upper limit of normal (uln) * ast no greater than 2.5 times uln renal * creatinine no greater than uln cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior allergic reactions to compounds of similar chemical or biological composition to perifosine * no other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * no ongoing or active infection * no other concurrent uncontrolled medical illness, psychiatric illness, or social situation that would preclude study entry prior concurrent therapy: biologic therapy * at least 3 months since prior adjuvant immunotherapy * no prior immunotherapy for recurrent/metastatic disease chemotherapy * no prior chemotherapy (including regional therapy) * no other concurrent cytotoxic chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * at least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy) surgery * at least 4 weeks since prior major surgery other * no other concurrent anticancer therapy or investigational agents

Keywords: recurrent melanoma stage iv melanoma