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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Brain and Central Nervous System Tumors
  • Carcinoid Tumor
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Central Nervous System Neoplasms
  • Childhood Langerhans Cell Histiocytosis
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Neoplasms
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell
  • Intraocular Melanoma
  • Islet Cell Tumor
  • Kidney Cancer
  • Lung Cancer
  • Malignant Carcinoid Syndrome
  • Melanoma
  • Melanoma (Skin)
  • Neoplasms
  • Neoplastic Syndrome
  • Nervous System Neoplasms
  • Neuroendocrine Carcinoma of the Skin
  • Neuroendocrine Tumors
  • Pheochromocytoma
  • Skin Neoplasms
  • Uveal Neoplasms

NCT number NCT00002947
Study type Interventional
Source Yale University
Contact
Status Terminated
Phase Phase 1
Start date October 1996
Completion date August 2004

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