Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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.

Detailed description: 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: 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

Relevance to patient case: not relevant