Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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