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

Completed · Not applicable

Conditions studied: Cervical, Ovarian, Lung, Breast, Renal

In brief

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.

Key facts

Study ID

NCT00972205

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2007-12-01

Expected to finish

2009-06-01

Last updated by the study team

2012-07-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The following patient populations are not eligible for study:
• Women of childbearing potential and potentially fertile men will be excluded unless using an effective contraception (ie. a barrier intrauterine device (IUD), birth control pill, or condom), during the treatment. Women who are pregnant or nursing will also be excluded.
• Patients with significant intercurrent disease.
• Human Immunodeficiencey virus (HIV) seropositive patients. Note: There may be an impact of CBT-1 on the pharmacokinetics of the drugs used in the therapy of HIV.
• Ongoing serious infections that require parenteral antibiotics.
• Patients with significant central nervous system (CNS) disease, including a history of seizures within the last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements.
• Patients must not be eligible for surgery, or radiotherapy that is of known benefit to them, in terms of extension of survival. Patients with tumors sensitive to potentially curative chemotherapy must have failed such chemotherapy. Patients who have received radiation therapy may participate in this study one week after the conclusion of radiation therapy provided that the lesion being irradiated is not one that is being used to assess the efficacy of CBT-1 plus Taxol.
• History of significant coronary artery disease, cardiac arrhythmias requiring treatment, or history of other cardiac disease that in the judgment of the investigators, would compromise the patient's ability to tolerate the therapy.
• Patients with active bleeding due to peptic ulcer disease.
• History of anaphylactic reactions to paclitaxel or cremophor despite adequate premedication.
• Clinically significant bleeding disorders.
• Patients with solid organ allografts.
• Patients on daily gastric acid secretion inhibitors.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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