Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
This study is currently recruiting participants.
Verified July 2011 by Radio Isotope Therapy of America
Sponsor:
Radio Isotope Therapy of America
Collaborators:
Excel Diagnostic Imaging Clinics
RadioMedix
St. Luke's Episcopal Hospital, Texas
Information provided by:
Radio Isotope Therapy of America
ClinicalTrials.gov Identifier:
NCT00442533
First received: March 1, 2007
Last updated: August 4, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
Condition | Intervention | Phase |
---|---|---|
Neuroendocrine Tumors |
Drug: High Dose Indium-111 pentetreotide (Neuroendomedix) |
Phase 2 Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms. |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary paraganglioma-pheochromocytoma
nonsyndromic paraganglioma
MedlinePlus related topics:
Cancer
U.S. FDA Resources
Further study details as provided by Radio Isotope Therapy of America:
Primary Outcome Measures:
- Radiological response [ Time Frame: 3 months after each therapy cycle ] [ Designated as safety issue: No ]
Estimated Enrollment: | 200 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: High Dose Indium-111 pentetreotide (Neuroendomedix)
3 cycles of 500 mCi treatments every 10-12 weeks
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442533
Contacts
Contact: Susan Cork | 713-342-3203 | scork@exceldiagnostics.com |
Locations
United States, Texas | |
Excel Diagnostic Imaging Clinics | Recruiting |
Houston, Texas, United States, 77042 | |
St. Lukes Episcopal Hospital | Recruiting |
Houston, Texas, United States, 77225-0269 |
Sponsors and Collaborators
Radio Isotope Therapy of America
Excel Diagnostic Imaging Clinics
RadioMedix
St. Luke's Episcopal Hospital, Texas
Investigators
Principal Investigator: | Ebrahim Delpassand, M.D. | RITA Foundation |
More Information
No publications provided
Keywords provided by Radio Isotope Therapy of America:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2012
No publications provided
Responsible Party: | Ebrahim Delpassand, Rita Foundation |
ClinicalTrials.gov Identifier: | NCT00442533 History of Changes |
Other Study ID Numbers: | 06-2247 |
Study First Received: | March 1, 2007 |
Last Updated: | August 4, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Radio Isotope Therapy of America:
Carcinoid Islet Cell Cancer Paraganglioma Pheochromocytoma |
Additional relevant MeSH terms:
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on September 30, 2012