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| Sponsors and Collaborators: |
Yale University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002947 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
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 |
Radiation: indium In 111 pentetreotide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors |
| Estimated Enrollment: | 35 |
| Study Start Date: | October 1996 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| Study Chair: | John R. Murren, MD | Yale University |
More Information
| Study ID Numbers: | CDR0000065414, YALE-HIC-9041, NCI-G97-1154 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002947 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Thoracic Neoplasms Carcinoma, Basosquamous Pancreatic Neoplasms Pancreatic Polypeptide Thyroid Cancer, Medullary Octreotide Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Phenylalanine Lung Neoplasms Zollinger-Ellison Syndrome Neuroepithelioma Neoplasms, Basal Cell Kidney Diseases |
Nervous System Neoplasms Endocrine Gland Neoplasms Carcinoid Syndrome Letterer-Siwe Disease Lung Diseases, Interstitial Digestive System Neoplasms Eye Neoplasms Carcinoma, Islet Cell Insulinoma Endocrine System Diseases Adenoma, Islet Cell Carcinoma, Basal Cell Malignant Carcinoid Syndrome Carcinoma Carcinoma, Merkel Cell |
|
Thoracic Neoplasms Carcinoma, Basosquamous Pancreatic Neoplasms Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Neoplasms by Site Pathologic Processes Lung Neoplasms Neoplasms, Basal Cell Kidney Diseases Nervous System Neoplasms Endocrine Gland Neoplasms Lung Diseases, Interstitial Reticuloendotheliosis |
Digestive System Neoplasms Eye Neoplasms Nervous System Diseases Endocrine System Diseases Carcinoma, Basal Cell Adenoma, Islet Cell Malignant Carcinoid Syndrome Carcinoma Carcinoma, Merkel Cell Neuroectodermal Tumors Neoplasms Lung Diseases Pancreatic Diseases Gastrointestinal Neoplasms Carcinoid Tumor |
