Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Cancer, Brain and Central Nervous System Tumors, Childhood Langerhans Cell Histiocytosis, Gastrointestinal Carcinoid Tumor, Intraocular Melanoma, Islet Cell Tumor, Kidney Cancer, Lung Cancer, Melanoma (Skin), Neoplastic Syndrome, Neuroendocrine Carcinoma of the Skin, Pheochromocytoma

Intervention / Treatment
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* Radiation: indium In 111 pentetreotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: indium In 111 pentetreotide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrinoma, iris melanoma, stage IV melanoma, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, insulinoma, recurrent islet cell carcinoma, thyroid gland medullary carcinoma, prolactin-producing pituitary tumor, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, recurrent melanoma, WDHA syndrome, somatostatinoma, pancreatic polypeptide tumor, glucagonoma, childhood Langerhans cell histiocytosis, metastatic pheochromocytoma, recurrent pheochromocytoma, pulmonary carcinoid tumor, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III neuroendocrine carcinoma of the skin, recurrent neuroendocrine carcinoma of the skin