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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00785798 |
Purpose
The study will be a dose-finding, phase I study of the combination of vorinostat and PLD in patients with advanced lymphoma refractory to at least one prior systemic therapy. The study will also be a dose-escalating study of vorinostat 200mg to 400 mg twice daily for 7 days with PLD 30mg/m2 on day 3 every 21 days, with intrapatient dose escalation.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed Lymphomas Refractory Lymphomas |
Drug: Vorinostat Drug: Pegylated Liposomal Doxorubicin (PLD) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Trial of Vorinostat and Pegylated Liposomal Doxorubicin in Relapsed or Refractory Lymphomas |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
|
Drug: Vorinostat
200mg to 400 mg twice daily on days 1-7
Drug: Pegylated Liposomal Doxorubicin (PLD)
IV 30mg/m2 on day 3 of a 21-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1000 /mcL Platelets ≥75,000 /mcL Hemoglobin ≥ 9 g/dL Coagulation Prothrombin Time or INR ≤1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation Partial thromboplastin time (PTT) ≤1.5x the ULN unless the patient is receiving therapeutic anticoagulation.
Chemistry K levels Normal limits Mg levels Normal limits Renal Serum creatinine or calculated creatinine clearance ≤2.0mg/dL OR ≥40 mL/min for patients with creatinine levels > 2.0mg/dL Hepatic Serum total bilirubin Normal limits AST (SGOT) and ALT (SGPT) ≤ 3 X ULN Alkaline Phosphatase (liver fraction) ≤ 3 X ULN a Creatinine clearance should be calculated per institutional standard.
Exclusion Criteria:
Contacts and Locations| Contact: Noelle Sowers, RN | 203-737-2445 | noelle.sowers@yale.edu |
| Contact: Donna LaCivita, MPH | 203-737-2579 | donna.lacivita@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: Francine Foss, MD | |
| Principal Investigator: | Francine Foss, MD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Francine Foss, M.D. ) |
| Study ID Numbers: | 0711003269 |
| Study First Received: | November 4, 2008 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00785798 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Relapsed Lymphomas Refractory Lymphomas |
|
Anti-Inflammatory Agents Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Doxorubicin Lymphatic Diseases Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Central Nervous System Agents |