Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00002947
First received: November 1, 1999
Last updated: July 1, 2014
Last verified: July 2014
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors

Resource links provided by NLM:


Further study details as provided by Yale University:

Estimated Enrollment: 35
Study Start Date: October 1996
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002947

Locations
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Sponsors and Collaborators
Yale University
Investigators
Study Chair: John R. Murren, MD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00002947     History of Changes
Other Study ID Numbers: CDR0000065414, YALE-HIC-9041, NCI-G97-1154
Study First Received: November 1, 1999
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
childhood Langerhans cell histiocytosis
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
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

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Neoplasms
Carcinoid Tumor
Carcinoma
Carcinoma, Merkel Cell
Carcinoma, Renal Cell
Kidney Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Melanoma
Nervous System Neoplasms
Pheochromocytoma
Central Nervous System Neoplasms
Carcinoma, Neuroendocrine
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Uveal Neoplasms
Adenoma, Islet Cell
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 20, 2014