A Phase 2 interventional study of Tariquidar and Tc-94m Sestamibi in Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-17.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Diagnostic
Background:
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:
Background:
Objectives:
-To evaluate the feasibility of Tc-94m sestamibi as a PET imaging agent, which should allow greater resolution and quantitation and thereby make possible direct quantitative comparisons of tumor uptake before and after treatment with a P-glycoprotein antagonist.
Eligibility:
Design:
National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
PET sestamibi scans followed by tariquidar and repeat imaging
Drug: Tariquidar · Drug: Tc-94m Sestamibi
3 days after initial PET patients will receive tariquidar and repeat imaging.
Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI (National Cancer Institute) protocol for treatment of cancer will undergo a PET sestamibi scan
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.
Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.
Time frame: 3 days
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time frame: 69 months
| Milestone | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Not treated-pt had poor iv access | 1 |
Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.
| % change in Tc-94m Sestamibi SUVmax | PET Imaging With Tc-94m Sestamibi |
|---|---|
| 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 (-10 to 153) |
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
| participants | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Number of Participants With Adverse Events | 8 |
Collected over 69 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PET Imaging With Tc-94m Sestamibi | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Event | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 4/12 |
| Low HemoglobinBlood and lymphatic system disorders | 4/12 |
| ALT, SGPT (serum glutamic pyruvic transaminase)Metabolism and nutrition disorders | 2/12 |
| AST, SGOT(serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders | 2/12 |
| Magnesium, serum-low (hypomagnesemia)Metabolism and nutrition disorders | 2/12 |
| Alkaline phosphataseMetabolism and nutrition disorders | 1/12 |
| Bilirubin (hyperbilirubinemia)Metabolism and nutrition disorders | 1/12 |
| Calcium, serum-high (hypercalcemia)Metabolism and nutrition disorders | 1/12 |
| CreatinineMetabolism and nutrition disorders | 1/12 |
| Low Leukocytes (total WBC)Blood and lymphatic system disorders | 1/12 |
| Age, Categorical(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 1 |
| Age, Continuous(years) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Mean | 54.82 ± 8.11 |
| Sex: Female, Male(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Female | 4 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 3 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| United States | 12 |
| Performance Status: Eastern Cooperative Oncology Group (ECOG)(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Performance status: 0 | 2 |
| Performance status: 1 | 9 |
| Performance status: 2 | 1 |
| Performance status: 3 | 0 |
| Histology(Participants) | PET Imaging With Tc-94m Sestamibi |
|---|---|
| Colorectal cancer | 4 |
| Pancreatic cancer | 2 |
| Small cell lung cancer | 2 |
| Non-small cell lung cancer | 1 |
| Esophageal cancer | 1 |
| Prostate cancer | 1 |
| Ovarian cancer | 1 |
1 further baseline measures are reported on the registry.
Plan to share: No
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