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Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

Primary Purpose

Neuroendocrine Tumors

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Indium-111 pentetreotide

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma

Eligibility Criteria

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

Inclusion Criteria:

Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.
Patients must have evidence of residual multifocal active tumor.
All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.
All patients must have a Karnofsky performance status of at least 60.
Patients must be greater than 18 years of age.
Patients must have measurable and/or followable disease based on either clinical or radiologic exam.
Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.
An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (B-HCG or pelvic ultrasound).
If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.

Exclusion Criteria:

Karnofsky performance status of 50 or less.
Patients who are unable to give informed consent.
Patients under 18 years of age. There will be no upper age discrimination.
Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.
Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.

Sites / Locations

Excel Diagnostic Imaging Clinics
St. Lukes Episcopal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indium-111 pentetreotide

Arm Description

4 cycles of 500 mCi treatments every 10-12 weeks

Outcomes

Primary Outcome Measures

Change in solid tumor dimensions by CT scan.

Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups. Complete response Partial response No change or stable disease Progression

Secondary Outcome Measures

Frequency and severity of adverse events

Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria

Full Information

NCT ID

NCT00442533

First Posted

March 1, 2007

Last Updated

March 28, 2023

Sponsor

Radio Isotope Therapy of America

Collaborators

Excel Diagnostic Imaging Clinics, Radiomedix, Inc., CHI St. Luke's Health, Texas

1. Study Identification

Unique Protocol Identification Number

NCT00442533

Brief Title

Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

Official Title

High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

August 30, 2014 (Actual)

Study Completion Date

December 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Radio Isotope Therapy of America

Collaborators

Excel Diagnostic Imaging Clinics, Radiomedix, Inc., CHI St. Luke's Health, Texas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.

6. Conditions and Keywords

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

Neuroendocrine Tumors

Keywords

Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indium-111 pentetreotide

Arm Type

Experimental

Arm Description

4 cycles of 500 mCi treatments every 10-12 weeks

Intervention Type

Drug

Intervention Name(s)

Indium-111 pentetreotide

Other Intervention Name(s)

NeuroendoMedix

Intervention Description

4 cycles of 500 mCi treatments every 10-12 weeks

Primary Outcome Measure Information:

Title

Change in solid tumor dimensions by CT scan.

Description

Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups. Complete response Partial response No change or stable disease Progression

Time Frame

Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments

Secondary Outcome Measure Information:

Title

Frequency and severity of adverse events

Description

Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria

Time Frame

up to 6 months following the last cycle of therap

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy. Patients must have evidence of residual multifocal active tumor. All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved. All patients must have a Karnofsky performance status of at least 60. Patients must be greater than 18 years of age. Patients must have measurable and/or followable disease based on either clinical or radiologic exam. Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial. An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound). If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease. Exclusion Criteria: Karnofsky performance status of 50 or less. Patients who are unable to give informed consent. Patients under 18 years of age. There will be no upper age discrimination. Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period. Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ebrahim Delpassand, M.D.

Organizational Affiliation

RITA Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Excel Diagnostic Imaging Clinics

City

Houston

State/Province

Texas

ZIP/Postal Code

77042

Country

United States

Facility Name

St. Lukes Episcopal Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77225-0269

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

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