NCT00442533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2015

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

9.1 years

First QC Date

March 1, 2007

Last Update Submit

March 28, 2023

Conditions

Neuroendocrine Tumors

Keywords

CarcinoidIslet Cell CancerParagangliomaPheochromocytoma

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Complete response 2. Partial response 3. No change or stable disease 4. Progression

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

Secondary Outcomes (1)

  • Frequency and severity of adverse events

    up to 6 months following the last cycle of therap

Study Arms (1)

Indium-111 pentetreotide

EXPERIMENTAL

4 cycles of 500 mCi treatments every 10-12 weeks

Drug: Indium-111 pentetreotide

Interventions

Indium-111 pentetreotideDRUG

4 cycles of 500 mCi treatments every 10-12 weeks

Also known as: NeuroendoMedix
Indium-111 pentetreotide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Excel Diagnostic Imaging Clinics

Houston, Texas, 77042, United States

Location

St. Lukes Episcopal Hospital

Houston, Texas, 77225-0269, United States

Location

MeSH Terms

Conditions

Neuroendocrine TumorsCarcinoid TumorSomatostatinomaParagangliomaPheochromocytoma

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, NeuroendocrineCarcinoma, Islet CellPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ebrahim Delpassand, M.D.

    RITA Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President and CEO

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

August 1, 2005

Primary Completion

August 30, 2014

Study Completion

December 28, 2015

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

US(2)