Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: CCI-779 in Treating Patients With Metastatic 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 CCI-779 in treating patients who have metastatic melanoma.

Detailed description: OBJECTIVES:
  -  Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in patients with metastatic melanoma.
  -  Determine the toxic effects of this regimen in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.
  Patients are followed for survival.
  PROJECTED ACCRUAL: Approximately 40-50 patients will be accrued for this study within 12 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion
  -  Measurable disease
  -  At least 20 mm by conventional techniques OR
  -  At least 10 mm by spiral CT scan
  -  The following are not considered measurable:
  -  Bone lesions
  -  Leptomeningeal disease
  -  Ascites
  -  Pleural/pericardial effusion
  -  Inflammatory breast disease
  -  Lymphangitis cutis/pulmonis
  -  Abdominal masses not confirmed and followed by imaging techniques
  -  Cystic lesions
  -  Progressive disease
  -  No prior or concurrent CNS metastasis
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  More than 4 months
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin normal
  -  AST and ALT no greater than 2.5 times upper limit of normal
  -  Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed)
  -  Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors
  Renal:
  -  Creatinine normal OR
  -  Creatinine clearance at least 60 mL/min
  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
  -  HIV negative
  -  No prior allergic reactions to compounds of similar chemical or biological composition to study drug
  -  No ongoing or active infection
  -  No seizure disorder
  -  No autoimmune disease
  -  No psychiatric illness or social situation that would preclude study
  -  No other concurrent uncontrolled illness that would preclude study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No more than 1 prior adjuvant biological therapy regimen
  -  No more than 1 prior biological therapy regimen for advanced disease
  -  At least 6 months since prior biological therapy or biochemotherapy and recovered
  -  Prior isolated limb perfusion with biological agent allowed if not to sole site of disease
  Chemotherapy:
  -  See Biologic therapy
  -  Prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease
  -  No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy
  -  May be in addition to 1 prior biologic regimen for advanced disease OR
  -  May have had 1 prior biochemotherapy regimen for advanced disease
  -  At least 3 weeks since prior chemotherapy and recovered
  Endocrine therapy:
  -  At least 1 week since prior dexamethasone
  -  No concurrent glucocorticosteroid therapy
  Radiotherapy:
  -  See Disease Characteristics
  Surgery:
  -  See Disease Characteristics
  Other:
  -  At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin
  -  At least 3 weeks since other prior agents to treat malignancy
  -  At least 3 weeks since prior investigational agents
  -  No other concurrent investigational agents
  -  No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A

Relevance to patient case: not relevant