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High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Phase 2/Phase 3
18 Years
Open (Enrolling)
Neuroendocrine Tumors

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Trial Information

High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiological response

Outcome Time Frame:

3 months after each therapy cycle

Safety Issue:


Principal Investigator

Ebrahim Delpassand, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

RITA Foundation


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Neuroendocrine Tumors
  • Carcinoid
  • Islet Cell Cancer
  • Paraganglioma
  • Pheochromocytoma
  • Neuroendocrine Tumors



St. Lukes Episcopal Hospital Houston, Texas  77030
Excel Diagnostic Imaging Clinics Houston, Texas  77042