RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors.

OBJECTIVES:

• Determine the objective tumor response rate (i.e., partial or complete response) in patients with progressive metastatic neuroendocrine tumors treated with CCI-779.
• Determine the stable disease rate and duration, time to disease progression, median survival time, and 1-year survival rate in patients treated with this drug.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. 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 beyond CR or PR.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 5-15 months.

• Gastrointestinal Carcinoid Tumor
• Islet Cell Tumor
• Lung Cancer
• Neoplastic Syndrome

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed neuroendocrine tumor

  • Carcinoid histology OR carcinoma of pancreatic islet cell origin

    • No small cell variant, endocrine organ carcinomas, or adrenal gland malignancies (including paragangliomas)
  • Metastatic disease

• Measurable disease

  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Not amenable to surgery

• Documented progressive disease within the past 6 months, as defined by 1 of the following criteria:

  • At least 25% increase in radiologically or clinically measurable disease
  • Appearance of new lesions
  • Deterioration in clinical status
• Must have tumor lesions accessible for biopsy
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.25 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN (< 5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 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
• No active or ongoing infection
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Concurrent chronic somatostatin analogues for symptom control allowed provided treatment was initiated > 3 months before study entry

Radiotherapy

• More than 4 weeks since prior radiotherapy, including radioactive octreotide, and recovered

Surgery

• More than 6 weeks since prior surgery

Other

• More than 6 weeks since prior local therapy (e.g., chemoembolization or bland embolization)
• More than 4 weeks since prior investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy
• No other concurrent investigational agents