ZOLINZA NEWS HIGHLIGHTS Media Articles Related to Zolinza (Vorinostat)
Personalized Anti-Cancer Vaccine, BiovaxID(R), Targeting B-Cell Lymphomas Available In Europe On A Named-Patient Basis
Source: Immune System / Vaccines News From Medical News Today [2009.06.30]
Biovest International, Inc. (Other OTC:BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ), today announced that BiovaxID®, Biovest's personalized therapeutic anti-cancer vaccine, is available on a named-patient (compassionate-use) basis in Europe.
Yaupon Therapeutics Completes Patient Enrollment For Pivotal Phase 2 Study Of Clearazide For Treatment Of Cutaneous T-cell Lymphoma
Source: Lymphoma / Leukemia News From Medical News Today [2009.06.30]
Yaupon Therapeutics, a privately held specialty pharmaceutical company, has announced it has completed enrollment for a pivotal Phase 2 clinical trial for Clearazide for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages 1-2a). The study, which is being conducted under a Special Protocol Assessment (SPA) with the FDA, has enrolled 260 patients in 13 of the top cancer centers in the US.
Mantle Cell Lymphoma Consortium Scientific Workshop - Report From Sixth Annual Meeting Now Available
Source: Lymphoma / Leukemia News From Medical News Today [2009.06.25]
Almost 60 mantle cell lymphoma (MCL) specialists from around the world gathered in Atlanta, GA for the Lymphoma Research Foundation's (LRF) Sixth Annual Mantle Cell Lymphoma Consortium (MCLC) Scientific Workshop. Attendees heard presentations addressing several key issues including the biology of MCL, prognostic indicators, new molecular targets, chemoimmunotherapy, transplantation and novel therapeutic approaches.
Seattle Genetics Initiates Phase II Trial Of SGN-35 For Anaplastic Large Cell Lymphoma
Source: Lymphoma / Leukemia News From Medical News Today [2009.06.21]
Seattle Genetics, Inc. (NASDAQ:SGEN), announced that it has initiated a phase II clinical trial of SGN-35 for patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The Leukemia & Lymphoma Society Calls For Blood Cancer Research Program At The Department Of Defense
Source: Blood / Hematology News From Medical News Today [2009.06.19]
George Dahlman, senior vice president of public policy for The Leukemia & Lymphoma Society (LLS), testified today before the U.S. Senate Subcommittee on Defense Appropriations, calling for funding for a dedicated, stand-alone blood cancer research program at the Department of Defense (DoD).
Published Studies Related to Zolinza (Vorinostat)
A phase II trial of vorinostat (suberoylanilide hydroxamic acid) in metastatic breast cancer: a California Cancer Consortium study. [2008.11.01]
CONCLUSIONS: Although not meeting the RECIST response criteria for adequate single-agent activity, the observed tolerable toxicities and the potential for clinical benefit in terms of stable disease suggest that further assessment of vorinostat [generic for Zolinza] as a part of combination therapy with either chemotherapeutic or targeted agents in metastatic breast might be undertaken.
FDG-PET/CT for the Evaluation of Response to Therapy of Cutaneous T-cell Lymphoma to Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in a Phase II Trial. [2008.11]
INTRODUCTION: Harnessing the power of molecular imaging in particular positron emission tomography (PET) to assess response to therapy in early clinical trials has the potential to yield crucial data on efficacy and streamline drug development. Vorinostat [generic for Zolinza] (also known as SAHA, suberoylanilide hydroxamic acid) is a histone deacetylase (HDAC) inhibitor which alters gene transcription to inhibit proliferation and promote apoptosis... CONCLUSION: Further study will be required to determine the prognostic value of the initial PET/CT scan and response on follow-up scans.
Cotreatment with vorinostat enhances activity of MK-0457 (VX-680) against acute and chronic myelogenous leukemia cells. [2008.10.01]
CONCLUSIONS: Combined in vitro treatment with MK-0457 and vorinostat [generic for Zolinza] is highly active against cultured and primary leukemia cells. These findings merit in vivo testing of the combination against human AML and CML cells, especially against imatinib mesylate-resistant Bcr-AblT315I-expressing CML Cells.
Early phase II trial of oral vorinostat in relapsed or refractory breast, colorectal, or non-small cell lung cancer. [2008.10]
Vorinostat (Zolinza) is a histone deacetylase inhibitor that has demonstrated activity in patients with advanced solid tumors in phase I trials. A multicenter, open-label phase II trial of oral vorinostat 200, 300 or 400 mg bid for 14 days followed by a 7-day rest until disease progression or intolerable toxicity was conducted... Most patients, however, had limited drug exposure which did not allow a reliable efficacy analysis.
Vorinostat and sorafenib synergistically kill tumor cells via FLIP suppression and CD95 activation. [2008.09.01]
CONCLUSIONS: These data show that combined exposure of epithelial tumor cell types to sorafenib and vorinostat [generic for Zolinza] diminishes expression of multiple antiapoptotic proteins and promotes activation of the CD95 extrinsic apoptotic and the lysosomal protease pathways, and that suppression of c-FLIP-s expression represents a critical event in transduction of the proapoptotic signals from CD95 to promote mitochondrial dysfunction and death.
Clinical Trials Related to Zolinza (Vorinostat)
A Phase I/II Clinical Trial of an Experimental Cancer Drug in Combination With an FDA Approved Cancer Drug for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer [Terminated]
The reason for this study will be to find the safest maximum tolerated dose of oral
vorinostat in combination with erlotinib (Tarceva (TM)) that can be given to patients with
lung cancer who have relapsed or failed other therapy for the disease. Once the safest
maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial
will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also
be evaluated.
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors [Active, not recruiting]
The purpose of this investigational study is to determine the safety and tolerability of oral
suberoylanilide hydroxamic acid when administered in combination with standard doses of
pemetrexed and cisplatin for the treatment of advanced solid tumors.
SAHA +CHOP in Untreated T-Cell Non-Hodgkin's Lymphoma [Not yet recruiting]
Primary Objectives:
Phase I
1. Determine the toxicity profile and the maximum tolerated dose (MTD) of vorinostat when
administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
(CHOP)
Phase II
2. To evaluate the progression free survival for patients with T-cell NHL receiving the
combination of vorinostat and CHOP
Secondary Objectives (Phase I and II):
1. To evaluate the response rate for patients with T-cell NHL receiving the combination of
vorinostat and CHOP
2. To assess overall survival in patients with T-cell NHL treated with the combination of
vorinostat and CHOP.
3. Correlative studies will be done to assess the role of vorinostat mediated apoptosis in
combination with cytotoxic chemotherapy. Changes in marker expression from baseline to
post treatment will be correlated with patient clinical response.
4. Correlative studies will be done to assess cytokine, gene, and protein array signatures
for the various subsets of T-cell NHL.
Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies. [Recruiting]
Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme
that plays a key role in the regulation of cell survival, growth, and eventual cell death,
all of which play a role in cancer. As a result, this drug has the potential to affect a
tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently
under investigation in clinical trials. The primary objective of this study is to define the
maximum safest dose of vorinostat in combination with a standard chemotherapy agent,
docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.
Vorinostat, Isotretinoin and Carboplatin in Adults With Recurrent Glioblastoma Multiforme (GBM) [Recruiting]
Primary Objective (Phase I):
1. To determine the maximum tolerated dose (MTD) of vorinostat/isotretinoin (cRA),
carboplatin (CBT)/cRA and vorinostat/cRA/CBT combinations in adult patients with recurrent
glioblastoma multiforme (GBM) and anaplastic gliomas.
Primary Objective (Phase II):
- To determine the efficacy of vorinostat/cRA versus CBT/cRA versus vorinostat/cRA/CBT in
patients with recurrent GBM as determined by time to progression (TTP) using an adaptive
randomization phase II trial design.
Secondary Objectives (Phase II):
- To determine the radiological response, progression free survival at 6 months, overall
survival and unexpected toxicity in the three treatment arms.
- To obtain exploratory data regarding histone 3 and 4 acetylation and p21 levels in tumor
tissue and peripheral monocytes in a subset of surgical patients and in non-surgical
patients with available tissue from previous surgical procedures.
- To evaluate the occurrence of symptoms and correlate to disease progression and
tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module
(MDASI-BT) self-reporting tool.
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