Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors
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First Received Date ICMJE | April 5, 2005 | ||||||||
Last Updated Date | September 20, 2011 | ||||||||
Start Date ICMJE | May 2005 | ||||||||
Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE | |||||||||
Original Primary Outcome Measures ICMJE | |||||||||
Change History | Complete list of historical versions of study NCT00107458 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors | ||||||||
Official Title ICMJE | A Phase I Study of Valproic Acid in Children With Recurrent/Progressive Solid Tumors Including CNS Tumors | ||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of valproic acid in treating patients with recurrent or refractory solid tumors or CNS tumors. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study. For course 1, patients receive escalating doses of oral valproic acid (VPA) twice daily until a target serum trough VPA concentration range is maintained for 28 days. Patients who achieve the target serum trough VPA concentration range receive subsequent courses of oral VPA twice daily (at the dose found to maintain the target serum trough VPA concentration range) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. The first cohort of 6 patients receives VPA to achieve an initial target trough serum VPA concentration. If fewer than 2 of 6 patients in the first cohort experience dose-limiting toxicity (DLT), then a second cohort of 6 patients receives VPA to achieve the next higher target trough serum VPA concentration. If fewer than 2 patients from the second cohort experience DTL, then 6 additional patients are enrolled in this cohort to better define pharmacokinetics and DLT at this VPA concentration range. After completion of study treatment, patients are followed annually. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||
Condition ICMJE |
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Intervention ICMJE | Drug: valproic acid | ||||||||
Study Arm (s) | |||||||||
Publications * | Su JM, Li XN, Thompson P, Ou CN, Ingle AM, Russell HV, Lau CC, Adamson PC, Blaney SM. Phase 1 Study of Valproic Acid in Pediatric Patients with Refractory Solid or CNS Tumors: A Children's Oncology Group Report. Clin Cancer Res. 2010 Nov 29; [Epub ahead of print] | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Estimated Enrollment ICMJE | 18 | ||||||||
Completion Date | |||||||||
Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status*
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||
Ages | 2 Years to 21 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States, Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00107458 | ||||||||
Other Study ID Numbers ICMJE | CDR0000417845, COG-ADVL0419, NCI-05-C-0235, NCI-P6631 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Children's Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | November 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |