Title

Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
  • Phase

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    200
The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.
Study Started
Aug 31
2005
Primary Completion
Aug 30
2014
Study Completion
Dec 29
2015
Last Update
Apr 28
2017

Drug Indium-111 pentetreotide

4 cycles of 500 mCi treatments every 10-12 weeks

  • Other names: (Neuroendomedix)

Indium-111 pentetreotide Experimental

4 cycles of 500 mCi treatments every 10-12 weeks

Criteria

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.
No Results Posted