Neuroendocrine Tumors
Conditions
Keywords
Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma
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.
Interventions
DRUGIndium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Sponsors
Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
CHI St. Luke's Health, Texas
Radio Isotope Therapy of America
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in solid tumor dimensions by CT scan. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of adverse events | up to 6 months following the last cycle of therap | Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria |
Countries
United States
Outcome results
None listed