Clinical trials to evaluate potential new treatments for cancer and
other illnesses are an option for many patients. Studies are conducted
to determine whether promising approaches to cancer treatment,
prevention and diagnosis are safe and effective. No benefit can be
guaranteed from the use of investigational drugs and only a qualified
medical professional can determine who is and who is not a candidate
to participate in these studies.
Cutaneous T-cell Lymphoma
Non-Hodgkin's Lymphoma or Hodgkin’s Lymphoma
Advanced Bladder Cancer
Advanced Non-small Cell Lung Cancer.
(active but no longer recruiting patients)
Cutaneous T-cell Lymphoma (CTCL)
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number of
non-Hodgkin's T-cell lymphomas, including mycosis fungoides and Sezary syndrome, which have their primary manifestations in the skin. According to the Lymphoma Research Foundation, CTCL accounts for approximately 2% to 3% of the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed each year in the U.S.
In August 2007, we initiated patient enrollment in a Phase 1, open-label, multi-center study of pralatrexate with vitamin B12 and folic acid supplementation in patients with relapsed or refractory CTCL. We plan to enroll up to 56 evaluable patients in the study with the objective of determining the optimal dose and safety profile, including at least 20 patients at what we believe to be the optimal dose and schedule.
Click here for interim data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) in December 2008.
For more information about participating in this clinical trial, go to www.ClinicalTrials.gov
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Non-Hodgkin’s Lymphoma (NHL) or Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and the fifth leading cause of cancer death in the U.S. According to the American Cancer Society, approximately 66,000 patients are expected to be diagnosed with NHL in the U.S. in 2008.
In May 2007, we initiated patient enrollment in a Phase 1/2a, open-label, multi-center study of pralatrexate and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory NHL and Hodgkin’s disease. In July 2009, we completed patient enrollment in the Phase 1 portion of this study and initiated enrollment in the Phase 2a portion of the trial to assess the efficacy and safety of two different schedules of this combination in patients with NHL, both B- and T-cell, as well as in patients with Hodgkin’s lymphoma.
Click here for interim data presented at the 50th Annual Meeting of the American Society of Hematology in December 2008.
For more information about participating in this clinical trial, go to www.ClinicalTrials.gov
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Non-Small Cell Lung Cancer (NSCLC)
According to the American Cancer Society, lung cancer is the most common cause of cancer death among men and women in the United States. Approximately 159,390 Americans are expected to die from the disease in 2009 and an estimated 219,440 new cases of lung cancer will be diagnosed this year. NSCLC is the most common type of lung cancer, accounting for almost 80% of lung cancer cases.
In January 2008, we initiated patient enrollment in a Phase 2b, randomized, international, multi-center study comparing pralatrexate and Tarceva (erlotinib), both with vitamin B 12 and folic acid supplementation, in patients with Stage IIIB/IV NSCLC who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. We completed enrollment with 201 patients in July 2009. We currently expect to report top-line results of the study in the first half of 2010, although the actual timing of such report may vary based on a number of factors.
This clinical trial is active but no longer recruiting patients. For more information about this clinical trial, go to www.ClinicalTrials.gov
Note: Tarceva is a registered trademark of OSI Pharmaceuticals, Inc.
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Bladder Cancer
Bladder cancer is the ninth most common type of cancer. According to the American Cancer Society, an estimated 68,810 new cases of bladder cancer were expected to be diagnosed in the U.S. in 2008. Transitional cell carcinoma, or TCC, is the most common form of bladder cancer, accounting for more than 90% of all bladder cancers. There are no approved agents for the treatment of advanced or metastatic relapsed TCC of the urinary bladder.
In July 2008, we initiated patient enrollment in a Phase 2, open-label, single-arm, multi-center study of pralatrexate with vitamin B12 and folic acid supplementation in patients with advanced or metastatic relapsed TCC of the urinary bladder. The study will seek to enroll approximately 41 patients in up to 20 investigative sites worldwide.
For more information about clinical trials, go to www.ClinicalTrials.gov
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