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

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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.


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
Houston, Texas 77042
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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