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| ID | Type | Description | Link |
|---|---|---|---|
| YALE-HIC-9041 | |||
| NCI-G97-1154 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indium In 111 pentetreotide | Radiation |
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
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| Name | Affiliation | Role |
|---|---|---|
| John R. Murren, MD | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Comprehensive Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000098943 | Uveal Melanoma |
| D007516 | Adenoma, Islet Cell |
| D007680 | Kidney Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D009369 | Neoplasms |
| D015266 | Carcinoma, Merkel Cell |
| D010673 | Pheochromocytoma |
| D002292 | Carcinoma, Renal Cell |
| D055752 | Small Cell Lung Carcinoma |
| D015408 | Gastrinoma |
| D007340 | Insulinoma |
| D018273 | Carcinoma, Islet Cell |
| D018276 | Carcinoma, Medullary |
| D003969 | Vipoma |
| D013005 | Somatostatinoma |
| D005935 | Glucagonoma |
| D018304 | Esthesioneuroblastoma, Olfactory |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D010235 | Paraganglioma |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009447 | Neuroblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D020431 | Olfactory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| C081788 | pentetreotide |
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