Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00002947
First received: November 1, 1999
Last updated: July 1, 2014
Last verified: July 2014

November 1, 1999
July 1, 2014
October 1996
August 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002947 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
August 2004
August 2004   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002947
CDR0000065414, YALE-HIC-9041, NCI-G97-1154
No
Yale University
Yale University
National Cancer Institute (NCI)
Study Chair: John R. Murren, MD Yale University
Yale University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP