Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors (NCT00107458) | Clinical Trial Compass
CompletedPhase 1
Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors
United States26 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range2 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed\* malignant solid tumor, including CNS tumors, at original diagnosis or relapse
* Recurrent or refractory disease NOTE: \*Histologic confirmation not required for intrinsic brain stem or optic pathway tumors
* Measurable or evaluable disease, defined by 1 of the following criteria:
* Any unidimensionally measurable lesion ≥ 10 mm by standard MRI or CT scan for either solid or CNS tumors
* At least 1 nonmeasurable lesion that is evaluable by nuclear medicine, immunocytochemistry, tumor markers, cerebrospinal fluid cytology, or other reliable measures
* No known curative therapy exists
* No documented tumor involvement in the bone marrow
PATIENT CHARACTERISTICS:
Age
* 2 to 21
Performance status\*
* Lansky 50-100% (for patients ≤ 10 years of age)
* Karnofsky 50-100% (for patients \> 10 years of age)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 110 (ULN for this study is 45 U/L)
* Albumin ≥ 2 g/dL
Renal
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
* Creatinine based on age as follows:
* No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
* No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 t…
What they're measuring
1
Efficacy of oral etoposide at 50 mg/m2/day given concurrently with radiotherapy