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Phase 2 N=12 Diagnostic

PET Imaging With Tc-94m Sestamibi to Assess Resistance to Chemotherapy

Cancer

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist. — 44 % change in Tc-94m Sestamibi SUVmax

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Tariquidar (Drug); Tc-94m Sestamibi (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.
44
SECONDARY
Number of Participants With Adverse Events
8

Summary

Background: * Tc-94m sestamibi is a radioactive imaging drug approved by the Food and Drug Administration to help photograph and study bodily functions. * Tc-94m sestamibi accumulates in tumor cells and is eliminated from them in much the same way that some chemotherapy drugs are eliminated from cancer cells in patients with drug resistance. * P-glycoprotein is a protein found on the surface of some cancer cells. The protein causes the cells to pump out, or reject, some types of chemotherapy drugs. P-glycoprotein also makes the cells reject sestamibi. * Some drugs, including a drug called tariquidar, may block the pumping action of P-glycoprotein, giving the chemotherapy more time to work. Tariquidar can also help sestamibi stay in the cells longer. Objectives: -To evaluate the use of sestamibi for determining if chemotherapy is being rejected and if enough of the blocking drugs are present to stop the rejection. Eligibility: -Patients18 years of age and older with a tumor 2 cm or larger who are enrolled in or are eligible for enrollment in an active National Cancer Institute treatment protocol. Design: * Patients have two scans, one before receiving any drugs and a second 1-2 hours after receiving tariquidar. The second scan is done 72 or more hours after the first. For both scans, Tc-94m sestamibi is injected into a vein and a series of pictures are taken with an imaging camera called a PET (positron emission tomography) scanner. The pictures show where the sestamibi distributes in the body and monitors the effects of tariquidar on drug resistance. Blood samples are collected during the scan to examine the effect of tariquidar on P-glycoprotein in normal cells. * Some patients may be asked to undergo a tumor biopsy to test for the presence of the P-glycoprotein on their cancer cells. This will be requested only in patients whose tumor is easily accessible and in whom a biopsy can be done with minimal risk.

Eligibility Criteria

  • INCLUSION CRITERIA:

Patients must be eligible for enrollment in an active NCI (National Cancer Institute) protocol for treatment of cancer.

Patients greater than or equal to 18 years old.

Performance Status ECOG (Eastern Cooperative Oncology Group) 0 - 2.

Patients must be able to give informed consent.

Women of childbearing potential must have a negative pregnancy test within 24 hrs of Tc-94m injection.

Patients who have previously received tariquidar will be eligible, since no study has systematically shown loss of MDR-1 (Multi Drug Resistance Protein 1)/Pgp expression in tumors following exposure to both tariquidar and an anticancer agent.

An index lesion greater than 1.5 cm will be required to optimize the PET (positron emission imaging) images.

EXCLUSION CRITERIA

Patients who are pregnant or breast-feeding will not be enrolled in order to prevent radiation exposure in the developing fetus or infant.

Patients weighing greater than 136 kg (the weight limit for the scanner table).

Patients having only tumor sizes less than 1.5 cm will be excluded.

HIV (human immunodeficiency virus) positive patients will be excluded to prevent potential drug interactions between tariquidar and antiretroviral agents.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00082368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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