Study of Efficacy and Safety of Valproic Acid in Chronic Lymphocytic Leukemia (CLL)
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether Valproic acid, as a single agent is effective in the treatment of Chronic Lymphocytic Leukemia which has relapsed or is refractory to therapy with standard drugs.
| Condition | Intervention |
|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Valproic acid |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia |
- Best clinical response as defined by NCIWG criteria for CLL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Hematological toxicity (graded according to NCIWG criteria for CLL) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Non- hematological toxicity (graded according to NCI common toxicity criteria) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Valproic acid |
Drug: Valproic acid
Tab. Valproic acid will be started at a dose of 10 mg per kg per day in two or three divided doses. If well tolerated the dose will be increased to a maximum of 20 mg per kg per day and continued for a period of 3 months. The drug will be continued for another 3 months for a maximum of 6 months in responding patients. The drug will be stopped in all those who develop intolerable side effects or develop disease progression during therapy.
Other Names:
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Detailed Description:
Chronic lymphocytic leukemia (CLL) is a disease characterized by a prolonged clinical course. Though various drugs such as alkylating agents, antimetabolites such as fludarabine and targeted antibodies such as rituximab are effective against this condition, relapses are frequent and cure is rare. There exists a subset of CLL patients who are refractory to many of these first line agents. Though one or the other of the above mentioned class of drugs can be substituted for patients who have relapsed or have refractory disease, no therapy has been conclusively proven to have survival advantage in this condition. The costs and toxicities add to the burden of these therapies. Valproic acid is a well studied drug used for the treatment of epilepsy for over 30 years. It has a well documented side effect profile, is generally well tolerated and is inexpensive. Recently, it has been shown to be an inhibitor of the enzyme, Histone de-acetylase(HDAC). Inhibition of HDAC promotes apoptosis, and could lead to the death of CLL cells which harbor defective apoptotic mechanisms. In vitro studies have proven the ability of therapeutic concentrations of Valproic acid to achieve cell kill in cultures of CLL cells. This study aims to identify whether valproic acid, used in standard doses has single agent activity against CLL and to assess its tolerance in these patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Active CLL (as defined by the National Cancer Institute Working Group)
- Patients must have received at least one prior therapy for CLL and have been treated with a nucleoside analogue.
- Age 18 years or older.
- Good general condition as defined by an Eastern cooperative oncology group- performance status (ECOG-PS) </=2.
- Absolute neutrophil count>1500/cmm and platelet count >30,000/cmm unless the low counts are due to the disease.
- Adequate liver function (bilirubin<2 mg/dL,ASTorALT <3Xthe upper limit of normal) and renal function (serum creatinine<2 mg/dL or creatinine clearance>30 mL/min) unless abnormalities are as a result of disease involvement.
- Full recovery from previous treatments.
Exclusion Criteria:
- Any therapy for CLL within 4 weeks before initiating treatment on this study.
- Pregnancy.
Contacts and Locations| Contact: Vinod Raina, MD, FRCP | 91-11-2659 3679 ext 3659 | vinodraina@hotmail.com |
| Contact: Prasanth Ganesan, MD | 91-99681-47800 | pg1980@gmail.com |
| India | |
| Institute Rotary Cancer Hospital, All India Institute of Medical Sciences | Recruiting |
| New Delhi, Delhi, India, 110029 | |
| Contact: Vinod Raina, MD, FRCP 91- 11- 2659 3679 vinodraina@hotmail.com | |
| Contact: Prasanth Ganesan, MD 91-99681-47800 pg1980@gmail.com | |
| Principal Investigator: Vinod Raina, MD, FRCP | |
| Sub-Investigator: Prasanth Ganesan, MD | |
| Principal Investigator: | Vinod Raina, MD, FRCP | Institute Rotary Cancer Hospital, AIIMS, New delhi, India |
More Information
Publications:
| Responsible Party: | Dr. Vinod Raina, Institute Rotary Cancer Hospital, AIIMS |
| ClinicalTrials.gov Identifier: | NCT00810680 History of Changes |
| Other Study ID Numbers: | IRCH-VAL-01 |
| Study First Received: | October 21, 2008 |
| Last Updated: | December 17, 2008 |
| Health Authority: | India: Drugs Controller General of India |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
chronic lymphocytic leukemia relapsed refractory valproic acid valproate |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Valproic Acid Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013