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Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Primary Purpose

Brain and Central Nervous System Tumors, Childhood Langerhans Cell Histiocytosis, Gastrointestinal Carcinoid Tumor

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
indium In 111 pentetreotide
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 1, 2014
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002947
Brief Title
Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
Official Title
A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
October 1996 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
indium In 111 pentetreotide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Murren, MD
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States

12. IPD Sharing Statement

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Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

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