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Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer



Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

For Condition: Thyroid Cancer,Renal Cell Cancer,Kidney Cancer,Lung Cancer,Melanoma,Eye Cancer,Head and Neck Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Yale Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the preliminary antitumor activity of indium In 111 pentetreotide. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnMurren,  Study Chair,  Yale Cancer Center

Yale Comprehensive Cancer Center
New Haven,  Connecticut,  06520-8028
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065414;  YALE-HIC-9041,NCI-G97-1154
Study Start Date: July 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002947

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