Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Descriptive Information
Brief Title † Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
Official Title † A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
Brief 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.
Detailed 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 Phase Phase 1
Study Type † Interventional
Study Design † Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † 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
Intervention † Radiationindium In 111 pentetreotide
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Radiation
Estimated Enrollment † 35
Start Date † October 1996
Completion Date August 2004
Primary Completion Date August 2004
Eligibility Criteria † DISEASE CHARACTERISTICS: Histologically proven malignancy with no alternate treatments available Measurable or evaluable progressive disease Somatostatin receptors present on tumor and uptake demonstrated on diagnostic scan with OctreoScan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Total bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 40 mL/min Other: No active infections Not HIV positive No coexisting medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior wide field radiation therapy Surgery: Recovery from prior surgery
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00002947
Organization ID CDR0000065414
Secondary IDs †† YALE-HIC-9041, NCI-G97-1154
Responsible Party Sponsor
Study Sponsor † Yale University
Collaborators †† National Cancer Institute (NCI)
Investigators † Study Chair: John R. Murren, MD, Yale University
Information Provided By
Verification Date July 2014
First Received Date † November 1, 1999
Last Updated Date July 1, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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