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.

Condition	Treatment or Intervention	Phase
Lung Cancer Renal Cell Cancer Head and Neck Cancer Melanoma Thyroid Cancer Eye Cancer Kidney Cancer	Drug: indium In 111 pentetreotide	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

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

Study chairs or principal investigators

John R. Murren,  Study Chair,  Yale Cancer Center   

Study ID Numbers:  CDR0000065414; YALE-HIC-9041; NCI-G97-1154
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002947
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08