Protocol Number: 04-C-0177

Title:

A Pilot Study of Tc-94m Sestamibi PET MDR Imaging

Number:

04-C-0177

Summary:

This study will use a drug called Tc-94m sestamibi to study drug resistance in patients with cancer. 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; it also makes the cells reject sestamibi. A drug called tariquidar may block this pumping action, giving the chemotherapy more time to work. Tariquidar can also help sestamibi stay in the cells longer.

For this study, sestamibi is coated with a radioactive material, Tc-94m or Tc-99m, and photographed in the body using positron emission tomography (PET) scanning to see if 1) chemotherapy is being rejected, and 2) enough tariquidar is present to stop the rejection.

Patients18 years of age and older with a tumor 2 cm or larger who are enrolled in, or eligible for, enrollment in an active National Cancer Institute treatment protocol may participate in this study.

Patients have two PET scans-one before receiving any drugs and another after being given tariquidar. The second scan is done 72 or more hours after the first. For the scans, sestamibi is injected into a vein and a series of pictures are taken with a camera that detects radioactivity. The pictures show where the sestamibi distributes in the body and monitors the effects of tariquidar on drug resistance. Blood samples are also collected. The total blood drawn is less than 3 tablespoons.

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Patients must be eligible for enrollment in an active NCI protocol for treatment of cancer.

Patients greater than or equal to 18 years old.

Performance Status ECOG 0 - 2.

Patients must be able to give informed consent.

Women of childbearing potential must have a negative pregnancy test.

Patients who have previously received tariquidar will be eligible, since no study has systematically shown loss of MDR1/Pgp expression in tumors following exposure to both tariquidar and an anticancer agent.

An index lesion greater than 2 cm will be required to optimize the PET 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 2 cm will be excluded.

HIV positive patients will be excluded to prevent potential drug interactions between tariquidar and antiretroviral agents.

Special Instructions: Currently Not Provided

Keywords:

Multi-Drug Resistance Reversal

Tariquidar

MIBI

Renal Cancer

Adrenal Cancer

Recruitment Keywords:

Cancer

Conditions:

Neoplasms

Investigational Drug(s):

Tariquidar

Tc-94m Sestamibi

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Advani R, et al. Treatment of refractory and relapsed acute myelogenous leukemia with combination chemotherapy plus the multidrug resistance modulator PSC 833 (Valspodar). Blood. 1999 Feb 1;93(3):787-95. PMID: 9920827

Agrawal M, et al. Increased 99mTc-sestamibi accumulation in normal liver and drug-resistant tumors after the administration of the glycoprotein inhibitor, XR9576. Clin Cancer Res. 2003 Feb;9(2):650-6. PMID: 12576431

Bakker M, et al. 99mTc-Sestamibi scanning with SDZ PSC 833 as a functional detection method for resistance modulation in patients with solid tumours. Anticancer Res. 1999 May-Jun;19(3B):2349-53. PMID: 10472354

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Bethesda, Maryland 20892. Last update: 08/07/2004