Antineoplastic Agents

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Paclitaxel

Albumin-Bound Paclitaxel

Antacids

Histamine H2 Antagonists

Technetium Tc 99m Sestamibi

Anti-Ulcer Agents

polysaccharide-K

Tubulin Modulators

Antimitotic Agents

Radiopharmaceuticals

Paclitaxel 135 mg/m\^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days.

paclitaxel

CBT-1 500 mg/m\^2 oral dose daily for 7 days in divided doses 3 times a day. Cycle days 1-7, repeated every 21 days. no antacids, H2 blocker, or gastric acid inhibiting agents will be administered within 4 hours before or after each daily dose.

CBT-1(Registered Trademark)

20 mCI baseline scan day 0; 20 mCI scan on 6th day of CBT-1 administered.

Tc 99m sestamibi

Susan S Bates, M.D.

Background:

* Some cancer cells have a large amount of a protein called P-glycoprotein, which can pump certain chemotherapy drugs out of their cells. This pump may be part of the reason why it is difficult to shrink some cancers with chemotherapy.
* In laboratory experiments, the drug CBT-1(Registered Trademark) blocked the P-glycoprotein pump, resulting in accumulation of higher amounts of chemotherapy inside the cancer cells, making the chemotherapy more effective.
* Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers, including lung, ovarian, breast, renal, cervical and others.

Objectives:

* To determine whether CBT-1(Registered Trademark) can block the P-glycoprotein pump on cancer cells and whether it inhibits the action of the pump found in normal blood cells and liver tissue.
* To evaluate the effectiveness of combination therapy using CBT-1(Registered Trademark) and paclitaxel in treating solid tumors and to determine whether the two drugs together are more effective than paclitaxel alone.

Eligibility:

-Patients over 18 years of age who have a solid tumor that cannot be treated successfully with standard treatments.

Design:

-Patients receive CBT-1(Registered Trademark) and paclitaxel in 21-day cycles. Treatment continues for two cycles after all the cancer is gone, or until it is decided to surgically remove some or all of the remaining cancer, or until the cancer has grown to the point where it defined as progressive disease.

For each cycle, patients take CBT-1(Registered Trademark) by mouth in three divided doses daily for 7 days. On day 6, paclitaxel is given through a vein over 3 hours.

Blood tests are done before starting CBT-1(Registered Trademark) and repeated periodically throughout treatment.

Imaging studies computed tomography or magnetic resonance imaging (CT or MRI) are done every two cycles. In addition, for the first cycle only, patients undergo imaging of tumors and normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of CBT-1(Registered Trademark). This scan helps show how well the P-glycoprotein pump is being blocked by the treatment.

Background:

This is a pharmacodynamic study aimed at evaluating the efficacy of CBT-1(Registered Trademark) as a modulator of Pgp-mediated drug efflux in patient tumors and normal tissues. The study will build on over a decade of experience with 99mTc-sestamibi imaging and rhodamine accumulation and efflux in normal circulating CD56 plus cells as surrogates for Pgp function. CBA Research, Inc., has carried out Phase I and II testing of CBT-1(Registered Trademark) as a drug resistance reversal agent, but has not yet confirmed that the inhibitor is able to block drug efflux.

Objectives:

Evaluate the impact of CBT-1(Registered Trademark) on the hepatic accumulation and retention of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies.

Evaluate the impact of CBT-1(Registered Trademark) on P-glycoprotein-mediated efflux from CD56 plus peripheral mononuclear cells.

Eligibility:

Patients over 18 years of age who have histologic confirmation of relapsed/refractory cancer, following at least once standard treatment regimen, for whom there is no known standard therapy option capable of extending life expectancy. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, and have hematologic, renal, hepatic, and metabolic parameters suggestive of adequate organ function.

Design:

Patients will be treated according to CBA Research Phase II trial of CBT-1 and Taxol. Patients will begin protocol treatment with orally administered CBT-1(Registered Trademark) in two or three divided doses daily for 7 days. On day 6, 135 mg/m\^2 paclitaxel will be administered by intravenous infusion over 3 hours. Prior to the initiation of CBT-1(Registered Trademark), and on Day 6, patients will undergo blood sampling for the rhodamine assay in CD56 plus circulating mononuclear cells. In addition, patients will undergo imaging of tumors and normal tissue with the 99mTc-sestamibi radionuclide scan. These two assays have shown convincing inhibition of Pgp-mediated drug efflux in past studies with Pgp inhibitors such as tariquidar and valspodar. Twelve patients are planned for enrollment to this study, which is powered to determine a difference between the control scan and the post-treatment scan but not to compare CBT-1(Registered Trademark) with previous inhibitors tested in the intramural program.

Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors

A Pharmacodynamic Study of the P-glycoprotein (Pgp) Antagonist, CBT-1(Registered Trademark), Evaluating Pgp Inhibition in Tumors and Normal Tissues

An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: \[(AUCpost - AUC baseline)/(AUC baseline)\] x 100.

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.

Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

See the Protocol Link module for further details about the RECIST Criteria.

National Cancer Institute (NCI)

Dr. Susan Bates

Patients will be treated with oral CBT-1 at a dose of 500 mg/m\^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.

Paclitaxel will be 135 mg/m\^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle.

Paclitaxel and CBT-1 to Treat Solid Tumors

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

Susan S. Bates, M.D.

As planned imaging data from 10 pts were analyzed.

Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition

Number of Participants With Adverse Events

Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.

Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment

Number of Participants Who Had an Overall Response

Overall Study

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.

TEP au MIBI

Jacques MONTEIL, MD

Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade malignant de novo or recurrence.

The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to chemotherapy, regardless of their initial extension. The failure of treatment is most often correlated with an incomplete answer or lack of response to chemotherapy as a result chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics of fixing, which can be used in oncological imaging (fixation by glial tumors of high grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in a traditional way, without changes in treatment protocols used in routine. Patients with a negative MIBI scan, will be watched with particular attention in order to detect insufficient response to chemotherapy. The only change, the care of patients, only for the achievement of an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping of MDR1, MRP1 and MRP2 to the patient.

Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

University Hospital, Limoges

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Cytarabine

Amonafide

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7

Amonafide + cytarabine

A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)

A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)

A Phase IIa Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Adult Patients With Acute Myeloid Leukemia (AML)

Antisoma Research

Fredrik Erlandsson

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Lung Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Rigid Spine Syndrome

Vinorelbine

XR9576

Tumor resistance to anti-cancer drugs is a major problem in cancer treatment. Studies have found that a protein (P-glycoprotein) on some cancer cells pumps chemotherapy drugs out of the cells, reducing treatment effectiveness. In laboratory tests, an experimental drug called XR9576, has blocked pumping by this protein. It is being used in this study to try to increase the amount of the anti-cancer drug vinorelbine, in cancer cells. Vinorelbine has been shown in several clinical trials to be effective against some advanced cancers, including breast, lung and ovarian, and is one of the drugs pumped out of tumor cells by P-glycoprotein.

Patients with cancer 18 years and older may be eligible for this study. Candidates will be screened with tests that may include blood and urine tests, electrocardiogram, echocardiogram, CT scans, X-rays, and nuclear medicine studies. A tumor biopsy may be done for diagnostic or research purposes.

Study participants will undergo tumor imaging with the radioactive drug Tc-99m Sestamibi. This drug accumulates in tumor cells and is eliminated from them in much the same way that some cancer drugs are eliminated from cells. The drug is injected into a vein and a series of pictures are taken with a gamma camera. After this baseline scan, patients will receive a dose of XR9576 and undergo a second scan 24 hours later. The scan will show whether XR9576 affects the accumulation and elimination of Sestamibi in tumor cells. This procedure may provide a way to monitor cancers for evidence of chemotherapy resistance and show if XR9576 can improve the effectiveness of therapy.

At least 10 days after the baseline and XR9576 scans, patients will begin the first of 3 or more 21-day cycles of vinorelbine treatment. On days 1 and 8 of each cycle, patients will receive a 30-minute infusion of XR9576 intravenously (through a vein) followed by vinorelbine, infused over a 6- to 10-minute period. (In some patients, XR9576 will be administered before only one of the two vinorelbine dosages.)

Physical examination, blood tests, and other procedures may be done periodically to monitor treatment.

Intrinsic and acquired drug resistance remain major obstacles in the treatment of cancer. Accumulating evidence indicates that in some malignancies P-glycoprotein can confer resistance, and that its reversal can improve therapeutic outcome. Clinical trials investigating P-glycoprotein antagonists have been hampered by the occurrence of unpredictable pharmacokinetic interactions, which have required dose reductions of the chemotherapeutic agents to avert excessive toxicity. XR9576 is a new P-glycoprotein antagonist that is more potent, has prolonged activity, and is potentially devoid of significant pharmacokinetic interactions. This phase I study seeks to identify the safety of XR9576 administration in combination with vinorelbine and determine the extent, if any, of a pharmacokinetic interaction between these two drugs. Clinical responses will also be determined.

Vinorelbine and XR9576 to Treat Cancer

A Clinical Trial of the P-Glycoprotein Antagonist, XR9576, in Combination With Vinorelbine in Patients With Cancer: Analysis of the Interaction Between XR9576 and Vinorelbine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paclitaxel and CBT-1(Registered Trademark) to Treat Solid Tumors	NCT00972205	Cervical Ovarian Lung Breast Renal	paclitaxel CBT-1(Registere... Tc 99m sestamib...	18 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade	NCT00551798	Hodgkin's Disea... Malignant Lymph... Chemoresistance	TEP au MIBI	18 Years -	University Hospital, Limoges
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)	NCT01066494	Acute Myeloid L...	Amonafide + cyt...	18 Years -	Antisoma Research
Vinorelbine and XR9576 to Treat Cancer	NCT00001944	Breast Cancer Cancer Lung Cancer Ovarian Cancer	Vinorelbine XR9576	-	National Institutes of Health Clinical Center (CC)
Vinorelbine and XR9576 to Treat Cancer	NCT00001944	Breast Cancer Cancer Lung Cancer Ovarian Cancer	Vinorelbine XR9576	-	National Institutes of Health Clinical Center (CC)
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)	NCT01066494	Acute Myeloid L...	Amonafide + cyt...	18 Years -	Antisoma Research

Spots Global Cancer Trial Database for pgp

Every month we try and update this database with for pgp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pgp

Every month we try and update this database with for pgp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pgp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.