Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

Inclusion Criteria

• Patients must have histologically or cytologically confirmed neuroendocrine tumours either of carcinoid histology or a carcinoma of pancreatic islet cell origin; small cell variant, endocrine organ carcinomas, and adrenal gland malignancies (including paragangliomas) are excluded from this study
• Patients must have progressive metastatic disease defined by one of the following occurring within 6 months of study entry:
• At least a 25% increase in radiologically or clinically measurable disease
• Appearance of any new lesion or
• Deterioration in clinical status
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
• Previous local therapy (e.g. chemoembolization or bland embolization) allowed if completed > 6 weeks prior to study entry; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
• Previous chemotherapy, investigational agents or radioactive therapies (e.g. radioactive octreotide) allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained BCNU or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease prior to study entry
• Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry
• Previous radiation therapy is allowed if > 4 weeks have elapsed since delivery of a dose likely to have myelotoxic effects (e.g. ≥ 3000cGy to fields including substantial marrow)
• Life expectancy of greater than 3 months
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Leukocytes ≥ 3.0 x 10^9/L
• Absolute neutrophil count ≥ 1.5 x 10^9/L
• Platelets >= 100 x 10^9/L
• Total bilirubin ≤ 1.25 x ULN
• AST(SGOT)/ALT(SGPT) ≤ 3 x ULN; < 5 x ULN with liver metastases
• Creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) calculated ≥ 60mL/min/1.73m^2
• Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
• Triglycerides =< 400 mg/dL (4.56 mmol/L)
• Must be willing and able to undergo tumor biopsy once before and once during experimental therapy; patients must have tumor lesions accessible for biopsy for correlative studies; in cases where there is a medical contraindication to tumor biopsy, exception may be granted upon discussion with the Principal Investigator/Chair
• The effects of CCI-779 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents concurrently or within 4 weeks of study entry
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
• Concurrent cancer from an