CONDYLOX SUMMARY
Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e. g. species of Juniperus and Podophyllum). Condylox® Gel 0.5% is formulated for topical administration. Each gram of gel contains 5 mg of podofilox in a buffered alcoholic gel containing alcohol, glycerin, lactic acid, hydroxypropyl cellulose, sodium lactate, and butylated hydroxytoluene.
Condylox® Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS).
Diagnosis
Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox® Gel 0.5%.
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NEWS HIGHLIGHTS
Clinical Trials Related to Condylox (Podofilox Topical)
Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant for Non-Hodgkin Lymphoma [Not yet recruiting]
RATIONALE: Bortezomib and vorinostat in the laboratory stop the growth of lymphoma cells
and make them more likely to die. Giving bortezomib together with vorinostat after an
autologous stem cell transplant may thus kill any lymphoma cells that remain after
transplant.
PURPOSE: This phase II trial is studying the side effects and how well bortezomib and
vorinostat work in treating patients with non-Hodgkin lymphoma after an autologous stem cell
transplant.
Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer [Not yet recruiting]
The subjects are being asked to take part in the Phase I or Phase II portion of a research
study of a new investigational drug, LBH589, in combination with chemotherapeutic agents,
carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered
"investigational" because it has not been approved for commercial use in the treatment of
cancer by the U. S. Food and Drug Administration (FDA). Etoposide and carboplatin are
chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer.
LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by
blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against
cancer in laboratory studies and in studies using animals; however, it is not known if this
medicine will show the same activity in humans. As of May 2006, approximately 100 patients
have received treatment with either an intravenous or capsule form of LBH589. Only the
capsule form of LBH589 will be used in this study.
The main goal during the Phase I portion of this research study is to find out the highest
and safest dose of LBH589 that can be given in combination with carboplatin with etoposide
in subjects with lung cancer without causing severe side effects. The main goal of the Phase
II portion of this study is to find how the subject's lung cancer responds to the LBH589 in
combination with carboplatin and etoposide at the highest and safest dose that was given in
Phase I.
The subject may be enrolled in either Phase I or Phase II of the trial, depending on when
they entered the study, but they will not be enrolled in both phases.
This study will also investigate how the subject's body processes the combination of LBH589
and carboplatin with etoposide. To determine this, the investigators will measure the
amount of study drug in the subject's blood. This will be done with a series of blood
tests, called pharmacokinetic (PK) tests. Pharmacokinetics is the study of how the study
drug moves through the body. Other purposes of this study will be to sample the subject's
genetic material (DNA/RNA) as well as to determine biomarkers in their blood. (For some
cancers, biomarkers are a way to measure the extent of their disease or the effects of
treatment.) These samples will also be stored for future studies.
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