Trial Information
Summary: If you have mycosis fungoides type CTCL and have experienced treatment failure or lack of tolerance with systemic or skin directed treatments you may be eligible for this clinical trial.
Physicians are currently seeking subjects to participate in this
open-label, dose-escalation, followed by double-blind, randomized
clinical research study of an investigational agent. Eligible
subjects will receive weekly IV infusions of the investigational
agent. Subjects are asked to come to the clinic for at least 16
visits during a 22 week period.
Qualified subjects receive all evaluations and procedures
related to the study at no cost, including physical examinations,
laboratory tests, ECG, and CT-scan. Blood draws and biopsies will
be done periodically.
Inclusion Criteria includes:
- Biopsy proven MF with a CD4 positive phenotype
- MF stage IB to IVB
- Refractory or intolerant to at least two prior therapies
- Male or female, at least 18 years of age
- Signed informed consent
Exclusion Criteria includes:
- Sezary syndrome
- Prior treatment with combination chemotherapy within six
months
- Prior treatment with Total Skin Electron Beam (TSEB) therapy
within one year
- Prior treatment with Campath (alemtuzumab)
- Prior treatment with more than three regimens of single agent
chemotherapy
- Treatment within 4 weeks prior to study with topical
Targretin®, skin directed therapies or systemic anticancer
therapies.
- Most past or current cancers
- Serious intercurrent medical condition
- Acute or chronic infectious disease
- Breast feeding women or women with a positive pregnancy
test
- Patients of childbearing potential must practice adequate
contraception
For more information,
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Contact:
Dr. Herve Bachelez`, MD, PhD.
Hôpital Saint-Louis
Service de Dermatologie 1
1 Avenue Claude Vellefaux
Paris Cedex 10, France, 75475
Telephone: +33142499817
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: June 1, 2008 at 6:31:45 AM