Clinical trial NCT00442533: Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
Official title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neuroendocrine Tumors
Keywords: Carcinoid
Islet Cell Cancer
Paraganglioma
Pheochromocytoma
Lead sponsor: Radio Isotope Therapy of America
Sponsor class: OTHER
Collaborators: name: Excel Diagnostic Imaging Clinics
name: Radiomedix, Inc.
name: CHI St. Luke's Health, Texas
First posted: 2007-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 (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.

Primary outcomes:
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
Secondary outcomes:
measure: Frequency and severity of adverse events
timeFrame: up to 6 months following the last cycle of therap
Other outcomes:
Locations:
city: Houston
country: United States
facility: Excel Diagnostic Imaging Clinics
state: Texas
city: Houston
country: United States
facility: St. Lukes Episcopal Hospital
state: Texas
Study officials:
affiliation: RITA Foundation
name: Ebrahim Delpassand, M.D.
role: PRINCIPAL_INVESTIGATOR
References: