Neuroendocrine TumorsPhase 2/3NCT00442533
Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
A Phase 2/3 study testing Indium-111 pentetreotide in people with Neuroendocrine Tumors, run by Radio Isotope Therapy of America at 2 sites in United States.
Trial summary
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Indium-111 pentetreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to 28 Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Excel Diagnostic Imaging Clinics
Houston, Texas, 77042
St. Lukes Episcopal Hospital
Houston, Texas, 77225-0269
About this study
Official title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Indium-111 pentetreotide
- Keywords
- Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor, Somatostatinoma, Paraganglioma, Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indium-111 pentetreotideDrug
Also called NeuroendoMedix
4 cycles of 500 mCi treatments every 10-12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Indium-111 pentetreotide | Experimental | 4 cycles of 500 mCi treatments every 10-12 weeks Receives: Drug: Indium-111 pentetreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria
Measured: up to 6 months following the last cycle of therap
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startAug 2005
- Primary completion30 Aug 2014
- Study completion28 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radio Isotope Therapy of America
- Sponsor type
- University, hospital or other
- Collaborators
- Excel Diagnostic Imaging Clinics, Radiomedix, Inc., CHI St. Luke's Health, Texas
- Responsible party
- Principal investigator, Ebrahim Delpassand, Radio Isotope Therapy of America
- Investigators
- Ebrahim Delpassand, M.D., Principal investigator, RITA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442533
- Sponsor's protocol ID
- 06-2247
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2007
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
- ClinicalTrials.gov ID
- NCT00442533
- Acronym / sponsor ID
- 06-2247
- Conditions
- Neuroendocrine Tumors
- Keywords
- Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Radio Isotope Therapy of AmericaUniversity, hospital or other
- Collaborators
- Excel Diagnostic Imaging Clinics, Radiomedix, Inc., CHI St. Luke's Health, Texas
- Study start
- Aug 2005
- Primary completion
- 30 Aug 2014 (actual)
- Study completion
- 28 Dec 2015 (actual)
- First posted
- 2 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indium-111 pentetreotide | Experimental | Drug: Indium-111 pentetreotide4 cycles of 500 mCi treatments every 10-12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indium-111 pentetreotideAlso: NeuroendoMedix4 cycles of 500 mCi treatments every 10-12 weeks | Drug | Indium-111 pentetreotide |
Primary outcome
Change in solid tumor dimensions by CT scan.
Time frame: Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments
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
1 secondary outcome
Frequency and severity of adverse events
Time frame: up to 6 months following the last cycle of therap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebrahim Delpassand, M.D. principal investigator
RITA Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Indium-111 pentetreotide in people with Neuroendocrine Tumors, run by Radio Isotope Therapy of America at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in solid tumor dimensions by CT scan. (time frame: Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.