Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors

This study has been terminated.
(Enrollment was difficult)
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00944372
First received: July 21, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.


Condition Intervention Phase
Solid Tumors
Drug: Indium In-111 pentetreotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: July 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Control, age greater than or equal to 18 with normal renal function
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 2
Age 18 to less than 65 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 3
Age 18 to less than 65 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 4
Age 18 to less than 65 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 5
Age 65 to less than 75 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 6
Age 65 to less than 75 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 7
Age 65 to less than 75 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 8
Age greater than or equal to 75 with mild renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 9
Age greater than or equal to 75 with moderate to severe renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111
Experimental: Group 10
Age greater than or equal to 75 with end stage renal impairment
Drug: Indium In-111 pentetreotide
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
Other Names:
  • OctreoScan
  • In-111

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females 18 years of age and older.
  2. If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
  3. If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
  4. Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
  5. Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
  6. Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
  7. Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
  8. Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.

Exclusion Criteria:

  1. Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
  2. Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
  3. Patients who are pregnant, breastfeeding or lactating.
  4. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  5. Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944372

Locations
United States, Florida
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Iowa
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Louisiana State University, Division of Hem/Onc
New Orleans, Louisiana, United States, 70112
United States, Pennsylvania
Hospital of University of Pennsylvania, Division of Nuclear Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Herbert Neuman, MD Mallinckrodt
  More Information

No publications provided

Responsible Party: James Brodack, Ph.D., Mallinckrodt
ClinicalTrials.gov Identifier: NCT00944372     History of Changes
Other Study ID Numbers: 0050-02-763
Study First Received: July 21, 2009
Last Updated: July 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Tumor
somatostatin receptor

Additional relevant MeSH terms:
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014