Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
This trial is active, not recruiting.
|Treatment||high dose indium-111 pentetreotide|
|Phase||phase 2/phase 3|
|Sponsor||Radio Isotope Therapy of America|
|Collaborator||Excel Diagnostic Imaging Clinics|
|Start date||August 2005|
|End date||August 2014|
|Trial size||200 participants|
|Trial identifier||NCT00442533, 06-2247|
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 3 months after each therapy cycle
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy. - Patients must have evidence of residual multifocal active tumor. - All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved. - All patients must have a Karnofsky performance status of at least 60. - Patients must be greater than 18 years of age. - Patients must have measurable and/or followable disease based on either clinical or radiologic exam. - Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial. - An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (B-HCG or pelvic ultrasound). - If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease. Exclusion Criteria: - Karnofsky performance status of 50 or less. - Patients who are unable to give informed consent. - Patients under 18 years of age. There will be no upper age discrimination. - Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period. - Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.
|Official title||High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.|
|Principal investigator||Ebrahim Delpassand, M.D.|
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