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

NCT00944372 | Terminated Phase 4

• 1 other identifier: 0050-02-763
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Tumor; somatostatin receptor

Outcome Measures

Primary Outcomes (1)

• Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis

  Through 24 hours post dose

Secondary Outcomes (1)

• Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis

  Through 24 hours post dose

Study Arms (10)

Group 1

EXPERIMENTAL

Control, age greater than or equal to 18 with normal renal function

Drug: Indium In-111 pentetreotide

Group 2

EXPERIMENTAL

Age 18 to less than 65 with mild renal impairment

Drug: Indium In-111 pentetreotide

Group 3

EXPERIMENTAL

Age 18 to less than 65 with moderate to severe renal impairment

Drug: Indium In-111 pentetreotide

Group 4

EXPERIMENTAL

Age 18 to less than 65 with end stage renal impairment

Drug: Indium In-111 pentetreotide

Group 5

EXPERIMENTAL

Age 65 to less than 75 with mild renal impairment

Drug: Indium In-111 pentetreotide

Group 6

EXPERIMENTAL

Age 65 to less than 75 with moderate to severe renal impairment

Drug: Indium In-111 pentetreotide

Group 7

EXPERIMENTAL

Age 65 to less than 75 with end stage renal impairment

Drug: Indium In-111 pentetreotide

Group 8

EXPERIMENTAL

Age greater than or equal to 75 with mild renal impairment

Drug: Indium In-111 pentetreotide

Group 9

EXPERIMENTAL

Age greater than or equal to 75 with moderate to severe renal impairment

Drug: Indium In-111 pentetreotide

Group 10

EXPERIMENTAL

Age greater than or equal to 75 with end stage renal impairment

Drug: Indium In-111 pentetreotide

Interventions

Indium In-111 pentetreotide DRUG

Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide

Also known as: OctreoScan, In-111

Group 1; Group 10; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7; Group 8; Group 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18 years of age and older.
• 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.
• 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.
• 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.
• Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
• Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
• 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.
• Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.

You may not qualify if:

• Patients receiving Sandostatin LAR \< 21 days prior to dosing or Sandostatin Immediate Release (IM) \< 24 hours prior to dosing.
• 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).
• Patients who are pregnant, breastfeeding or lactating.
• Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
• Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (4)

University of Miami, Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Iowa Medical Center

Iowa City, Iowa, 52242, United States

Location

Louisiana State University, Division of Hem/Onc

New Orleans, Louisiana, 70112, United States

Location

Hospital of University of Pennsylvania, Division of Nuclear Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pentetreotide; Indium-111

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: July 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (4)