131MIBG to Treat Malignant Pheochromocytoma

Exclusion Criteria

• •Pregnant or lactating women will be excluded. A positive pregnancy test will exclude the patient from further participation in this protocol.
• •Children (less than 18 years of age) and patients older than 70 years of age will be excluded.
• •Patients will be further excluded if they have:
• •Impaired cardiovascular function (ejection fraction of less than 40%, symptomatic congestive heart failure, sustained blood pressure over 190/100, angina pectoris);
• •Abnormal coagulation parameters (PT and PTT elevated by 30% above the normal);
• •Hematocrit below 30%, hemoglobin below 10 g/dl, white blood cell count below 3000 per mm(3), absolute neutrophil count below 1000 per mm(3), platelet count below 100,000 per mm(3));
• •Any reason not to accept blood transfusions which may be needed as treatment for myelotoxicity from experimental \[131I\]-MIBG therapy;
• •Liver enzymes greater than 2.5 times the upper limit of normal; serum bilirubin greater than 1.5 times the upper limit of normal.
• •Renal dysfunction (serum creatinine greater than 2.0 mg/dl);
• •Life expectancy less than 3 months;
• •Weight over 136 kg, This is the limit for the scanning tables;
• •Combined blood withdrawal greater than 450 ml during the six weeks preceding the study;
• •Impaired mental capacity that precludes written informed consent.
• •Prior experimental treatment with \[131I\]-MIBG, \[90Y\]-octreotide (an alternative agent being investigated to treat pheochromocytoma), or chemotherapy will exclude the patient, if this treatment was received in the previous 3 months provided the patient meets all other entry criteria.
• •Labetalol, reserpine, calcium channel blockers, tricyclic anti-depressants, phenylephrine, phenylpropanolamine, pseudoephedrine, ephedrine, and some atypical anti-depressants/anti-psychotics interfere with uptake of \[131I\]-MIBG by pheochromocytomas. If a patient cannot change to a non-interfering pharmaceutical, they will be ineligible for the study.
• •Due to the potiential immunosuppressive effect of radiation therapy, patients with positive HIV are excluded from this study. Patients with hepatitis B or hepatitis C are excluded due to the potential of liver toxicity.
• •Patients who have received high dose chemotherapy with bone marrow transplant therapy or stem cell infusion are excluded.
• •Patients who have received radiation therapy to the pelvis and/or spine are excluded. Local radiation therapy to one site (excluding pelvis/spine) will be permitted provided that at least 1 year has lapsed and the patient meets all other entry criteria.