Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
Status: | Completed |
---|---|
Conditions: | Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/29/2017 |
Start Date: | August 2005 |
End Date: | December 29, 2015 |
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.
NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials