Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas

This is an interventional treatment trial for Small Cell Lung Cancer (SCLC) focused on measuring Lung cancer, Small cell lung cancer, Neuroendocrine tumor, Rhenium, Re 188-P2045 Read More

Inclusion Criteria:

• Age >/=18 years.
• Advanced, metastatic or locally recurrent, incurable neuroendocrine tumors (small cell lung cancer, extrapulmonary small cell lung cancer, large cell neuroendocrine lung carcinoma pulmonary carcinoid, GI carcinoid tumor
• Symptomatic CNS metastases: must have received therapy (surgery, XRT, gamma knife)
• Asymptomatic CNS metastatic disease: discuss with Study Chair.
• Histologically-or cytologically documented disease.
• Considered incurable by any combination of therapy including surgery, radiation, chemotherapy.
• ECOG Performance status 0-2
• Renal function: creatinine clearance > 40 mg/mlxmin (Cockroft-Gault)
• Adequate organ and marrow function by:
• Absolute neutrophil count (ANC) >/=1,500/mcL.
• Platelets >/= 100,000/mcL.
• Total bilirubin within normal institutional limits (WNL)
• AST (SGOT)/ALT (SPGT) </= 2.5 x upper limit of normal (ULN)
• Women (child-bearing potential) and men must use adequate contraception prior to study entry, for duration of study participation, and 90 days after completion of therapy.
• A female of child-bearing potential is any woman is one who has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Merkel cell carcinoma
• Leptomeningeal disease or carcinomatous meningitis
• Chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered > 3 weeks earlier.
• If the patient was receiving an oral agent, at least 4 half lives should have elapsed.
• Cannot receive any other investigational agent at the time of registration. At least 3 weeks should have elapsed since administration of an IV investigational agent or 4 half lives for an oral investigational agent.
• At least 28 days should have elapsed since administration of a long acting somatostatin analogue.
• Patients with known brain metastases are eligible (see criteria above). Leptomeningeal metastases are not eligible.
• Patients who have received external beam radiation to more than 20% of marrow.
• No prior radiation to the kidneys.
• Prior systemic radiotherapy are not eligible (except for prior I131 for thyroid cancer more than 1 year earlier).
• Receiving long term immunosuppressive medications for rheumatologic or other disease (e.g. low dose methotrexate, mecaptopurine etc).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to octreotide or other somatostatin analogues.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing (due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.)