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Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Age
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Sponsor
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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18 to 120
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Pharmaceutical / Industry
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CLBH589B2201
NCT00425555
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Trial Description
Summary This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma. Eligibility Criteria Inclusion criteria 1. Written informed consent obtained prior to any screening procedures 2. Age ≥ 18 years old 3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. 4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen. 5. Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen. 6. Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment. Exclusion criteria 1. Prior treatment with an HDAC inhibitor. 2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible. 3. Impaired cardiac function 4. Concomitant use of drugs with a risk of causing torsades de pointes 5. Patients who have received chemotherapy or any investigational drug or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy 6. Less than 3 months since prior electron beam therapy 7. Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis | | Ph: 862 778 8300 |
Trial Sites
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| U.S.A. |
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| Alabama |
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Birmingham |
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| | | | | | | | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham |
| | | Misty Winslett |
Ph: 205-502-9967 |
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Email:
mwinslett@uabmc.edu |
| | | Lauren C. Hughey, M.D. | Principal Investigator |
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| California |
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Duarte |
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| | | | City of Hope Comprehensive Cancer Center |
| | | Annette Brown |
Ph: 626-256-4673 Ext.63037 |
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Email:
abrown@coh.org |
| | | Jasmine M. Zain | Principal Investigator |
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Los Angeles |
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| | | Jonsson Comprehensive Cancer Center at UCLA |
| | | Donna Fernando |
Ph: 310-794-4376 |
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Email:
dfernando@mednet.ucla.edu |
| | | Lauren Pinter-Brown, M.D. | Principal Investigator |
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| Colorado |
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Aurora |
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| | | | University of Colorado Cancer Center at UC Health Sciences Center |
| | | Andrea Buchmeier |
Ph: 720-848-0635 |
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Email:
andrea.buchmeier@uchsc.edu |
| | | Theresa Pacheco, M.D. | Principal Investigator |
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| Florida |
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Miami |
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| | | | Florida Academic Dermatology Centers |
| | | Annika Grant |
Ph: 305-324-2110 Ext.110 |
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Email:
fadcresearch@bellsouth.net |
| | | Francisco Kerdel, M.D. | Principal Investigator |
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| Georgia |
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Atlanta |
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| | | | Study Site |
| | | Hanna Jean Khoury, M.D. |
Ph: 404 778 3932 |
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Email:
hkhoury@emory.edu |
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Augusta |
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| | | Medical College of Georgia Cancer Center |
| | | Kavita Natarajan, M.D. |
Ph: 706-721-2505 |
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| Illinois |
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Chicago |
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| | | | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| | | Lindsay Peters |
Ph: 312-695-1005 |
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Email:
l-peters@northwestern.edu |
| | | Timothy M. Kuzel | Principal Investigator |
| | | Rush Presbyterian-St. Luke's Medical Center |
| | | Michael Tharp, M.D. |
Ph: 312-942-2195 |
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| Indiana |
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Indianapolis |
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| | | | Indiana University Melvin and Bren Simon Cancer Center |
| | | Lawrence Mark, M.D., Ph.D. |
Ph: 317-274-7744 |
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Email:
lamark@iupui.edu |
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| Iowa |
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Iowa City |
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| | | | Holden Comprehensive Cancer Center at University of Iowa |
| | | Mary Shannon |
Ph: 319-356-3516 |
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Email:
mary-shannon@uiowa.edu |
| | | Vincent Liu, M.D. | Principal Investigator |
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| Massachusetts |
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Boston |
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| | | | Boston University Cancer Research Center |
| | | Becky Brown |
Ph: 617-414-1828 |
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Email:
Becky.brown@bmc.org |
| | | Marie-France Demierre | Principal Investigator |
| | | Dana-Farber/Brigham and Women's Cancer Center |
| | | Alexa Kimball, M.D. |
Ph: 617-726-6755 |
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| Nebraska |
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Omaha |
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| | | | UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| | | Carolyn Chamberlain |
Ph: 402-559-3848 |
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Email:
cchamberlain@unmc.edu |
| | | Julie M. Vose | Principal Investigator |
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| North Carolina |
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Durham |
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| | | | Duke Comprehensive Cancer Center |
| | | Elise Olsen, M.D. |
Ph: 919-668-5610 |
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Winston-Salem |
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| | | Wake Forest University Comprehensive Cancer Center |
| | | Jennifer MacLean |
Ph: 336-713-3539 |
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Email:
jemaclea@wfubmc.edu |
| | | Denise Levitan, M.D. | Sub-Investigator |
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| Ohio |
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Cincinnati |
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| | | | University Dermatology Consultants |
| | | Vivian Berger |
Ph: 513-475-7576 |
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Email:
bergervr@ucmail.uc.edu |
| | | Deborah Breneman, M.D. | Principal Investigator |
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| Oregon |
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Portland |
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| | | | Oregon Health and Science University Cancer Institute |
| | | Evi Roberson |
Ph: 503-494-4109 |
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Email:
roberson@ohsu.edu |
| | | Craig Okada, M.D. | Principal Investigator |
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| Pennsylvania |
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Pittsburgh |
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| | | | UPMC Cancer Centers |
| | | Sue A McCann |
Ph: 412-624-3782 |
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Email:
mccannsa@upmc.edu |
| | | Larisa Geskin, M.D. | Principal Investigator |
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| Tennessee |
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Germantown |
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| | | | Jones Clinic - Germantown |
| | | Michael Jones, M.D. |
Ph: 901-685-5969 |
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| Texas |
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Houston |
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| | | | M. D. Anderson Cancer Center at University of Texas |
| | | Carol Wilson |
Ph: 713-563-4655 |
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Email:
clwilson@mdanderson.org |
| | | Madeleine Duvic, M.D. | Principal Investigator |
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| Argentina |
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Buenos Aires |
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| Australia |
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Brisbane |
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Victoria |
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| Belgium |
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Gent |
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Leuven |
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Yvoir |
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| Canada |
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Helinski |
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Quebec |
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| France |
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Cede |
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Créteil |
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Lyon |
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Nantes |
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Paris |
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| Germany |
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Berlin |
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Frankfurt |
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Minden |
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Wuerzburg |
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| Hungary |
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Budapest |
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Debrecen |
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Szeged |
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| Italy |
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Bologna |
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Firenze |
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Napoli |
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Torino |
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Torrette di Ancona |
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| Spain |
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Barcelona |
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Llobregat |
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Madrid |
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| Switzerland |
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Zurich |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00425555
Information obtained from ClinicalTrials.gov on September 11, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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