Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
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.
Brain and Central Nervous System Tumors
Childhood Langerhans Cell Histiocytosis
Gastrointestinal Carcinoid Tumor
Head and Neck Cancer
Islet Cell Tumor
Neuroendocrine Carcinoma of the Skin
Radiation: indium In 111 pentetreotide
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002947
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||John R. Murren, MD||Yale University|