Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Lung Cancer Clinical Trial

Official title:

A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002947
• Other study ID #: CDR0000065414
• Secondary ID: YALE-HIC-9041NCI
• Status: Terminated
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 1, 2014
• Start date: October 1996
• Est. completion date: August 2004

Study information

• Verified date: July 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Radiation:
• indium In 111 pentetreotide

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,