Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

NCT00002947 | Terminated Phase 1

• 3 other identifiers: CDR0000065414YALE-HIC-9041NCI-G97-1154
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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; gastrinoma; insulinoma; recurrent islet cell carcinoma; thyroid gland medullary carcinoma; prolactin-producing pituitary tumor; iris melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; recurrent intraocular melanoma; stage IV 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

Interventions

indium In 111 pentetreotide RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Head and Neck Neoplasms; Uveal Melanoma; Adenoma, Islet Cell; Kidney Neoplasms; Lung Neoplasms; Melanoma; Neoplasms; Carcinoma, Merkel Cell; Pheochromocytoma; Carcinoma, Renal Cell; Small Cell Lung Carcinoma; Gastrinoma; Insulinoma; Carcinoma, Islet Cell; Carcinoma, Medullary; Vipoma; Somatostatinoma; Glucagonoma; Esthesioneuroblastoma, Olfactory

Interventions

pentetreotide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Paraganglioma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Olfactory Nerve Diseases; Cranial Nerve Diseases

Study Officials

• John R. Murren, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 26, 2004
• Study Start: October 1, 1996
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

US (1)