Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
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|ClinicalTrials.gov Identifier: NCT00002947|
Recruitment Status : Terminated
First Posted : March 26, 2004
Last Update Posted : July 2, 2014
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Childhood Langerhans Cell Histiocytosis Gastrointestinal Carcinoid Tumor Head and Neck Cancer Intraocular Melanoma Islet Cell Tumor Kidney Cancer Lung Cancer Melanoma (Skin) Neoplastic Syndrome Neuroendocrine Carcinoma of the Skin Pheochromocytoma||Radiation: indium In 111 pentetreotide||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the preliminary antitumor activity of indium In 111 pentetreotide.
OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide (OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, then every 6 months thereafter.
PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors|
|Study Start Date :||October 1996|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||August 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002947
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||John R. Murren, MD||Yale University|