Clinical trial · Interventional
Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
NCT00442533CI-TRIAL-00065245completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indium-111 pentetreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indium-111 pentetreotide
- description
- 4 cycles of 500 mCi treatments every 10-12 weeks
- interventionNames
- Drug: Indium-111 pentetreotide
Primary outcomes (1)
- measure
- Change in solid tumor dimensions by CT scan.
- timeFrame
- Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments
- description
- 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
Secondary outcomes (1)
- measure
- Frequency and severity of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.