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Sponsors and Collaborators: |
Columbia University Schering-Plough Celgene Corporation |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00629343 |
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
Condition | Intervention | Phase |
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Soft Tissue Sarcoma Mesothelioma |
Drug: Azacitidine In Combination With Temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma |
Estimated Enrollment: | 24 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
The primary objective of the study is to determine the clinical and laboratory toxicities as well as acceptability/tolerance of this dose schedule of combined drug treatment with temozolomide and azacitidine.
Secondary objectives include determination of biochemical response to azacitidine as defined as change in methylation status. We will specifically be looking at changes in genome wide methylation patterns as determined by two high-throughput platforms:
We will also monitor clinical response, time to progression and overall survival.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required initial laboratory data:
Exclusion Criteria:
Contact: Lilian Batista, BS | 212-305-6837 | lb2327@columbia.edu |
Contact: Pamela Pujols, BS | 212-305-1923 | pp2263@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Lilian Bastista, BS 212-305-6837 lb2327@columbia.edu | |
Principal Investigator: Robert N Taub, MD |
Principal Investigator: | Robert N Taub, MD | Columbia University Medical Center |
Responsible Party: | Columbia University Medical Center ( Robert Taub, MD ) |
Study ID Numbers: | AAAC3255 |
Study First Received: | February 26, 2008 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00629343 |
Health Authority: | United States: Institutional Review Board |
Neoplasms, Connective and Soft Tissue Malignant mesenchymal tumor Azacitidine Sarcoma Mesothelioma |
Temozolomide Adenoma Soft tissue sarcomas Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Neoplasms, Mesothelial Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |