LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

Inclusion Criteria

• •For inclusion in the study, patients must fulfill all of the following criteria:
• •1. Male or female at least 18 years of age at the time of first dosing
• •2. Patients must give signed informed consent before any study-related activities are conducted.
• •3. Patients in the United States must have given written authorization for the release of protected health information in compliance with HIPAA regulations; patients in other countries must provide appropriate authorization as needed by regulatory authorities in each country.
• •4. Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability.
• •5. Evidence of recent disease progression (radiological, biochemical, symptomatic) while the patient was either not receiving any therapy or was receiving a therapy that was deemed ineffective.
• •6. Measurable disease defined as that which can be measured in at least one dimension with a minimum size of 10 mm by CT scan. The patient must also have at least three baseline radiographic studies obtained in the previous twelve months with at least one scan obtained within six weeks of enrollment. If a patient being considered for enrollment on trial has not had three scans performed in the twelve months prior to enrollment and if in the opinion of the investigator a delay of one month will not impact the clinical course, then enrollment on protocol and the start of the lanreotide therapy can be delayed by one month or longer to obtain the additional time point. If in the opinion of the investigator such a delay may have adverse consequences then enrollment on the protocol should not be considered as an option
• •7. Confirmation of positive somatostatin receptor status (SRS) by Somatostatin Receptor Scintigraphy. Either of these studies will need to have been performed in the 6 months prior to the screening visit. Only if one has not been performed within the previous 6 months will a SRS study be required. if an SRS is required, it will be performed greater than or equal to 24 hours after a previous injection of subcutaneous octreotide).
• •8. Patients may not have had prior octreotide, long acting release (LAR)-octreotide, lanreotide or a therapeutic radiolabeled somatostatin analog (PRRT)
• •9. Eastern Cooperative Oncology Group (ECOG) 0-2.
• •10. Life expectancy of greater than 12 weeks.
• •11. Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 2 x the upper limit
• •12. Patients may have had prior radiation therapy. A minimum of 42 days must have elapsed between the end of radiotherapy and registration onto the study. Measurable disease must exist outside of the radiation field for eligibility.
• •13. Previous surgery: Previous major surgery is permitted provided that it was performed at least 28 days prior to patient registration.
• •14. Laboratory requirements \[parameter limits\]: Absolute granulocyte count (AGC) greater than 1.5 x 109/L; platelet count greater than100 x 109/L; serum bilirubin less than 1.5 x upper limit of normal (ULN); serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; serum amylase less than1.5 x ULN; serum lipase less than 1.5 x ULN; serum calcium less than 3 mmol/L; serum creatinine less than 1.5 x ULN
• •15. If female, the patient must not be pregnant (confirmed by negative pregnancy test) and must have the following documented via verbally given history:
• •* At least 1 year postmenopausal (natural cessation of menses), or
• •* Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to entry into the study), or
• •* If of childbearing potential and sexually active, she must be using or agree to use an acceptable form of contraception (oral, injected, transdermal or implanted contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine device); local methods such as condoms or sponges/vaginal tablets are only to be used as an additional form of contraception.
• •16. If the male patient has a partner of childbearing potential and he is sexually active, he must be using or agree to use a barrier method of contraception (condom with spermicidal preferred).
• •17. Be able to communicate and cooperate with the principal investigator and the staff and willing to comply with the study instructions