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Status:

COMPLETED

Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility:

All Genders

2-21 years

Phase:

PHASE1

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...

Detailed Description

OBJECTIVES: Primary * Determine the toxic effects of valproic acid (VPA) administered at doses required to maintain serum trough VPA concentrations of 100-150 mcg/mL or 150-200 mcg/mL in young patie...

Eligibility Criteria

Inclusion

  • 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 to 15 years of age)
  • No greater than 1.5 mg/dL (for patients over 15 years of age)
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neurologic deficits in patients with CNS tumors must be stable for ≥ 1 week before study entry
  • No uncontrolled infection
  • No known urea cycle disorders or other metabolic disorders
  • No other condition that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Recovered from prior immunotherapy
  • At least 7 days since prior hematopoietic growth factors that support platelet or WBC number or function
  • At least 7 days since prior antineoplastic biologic agents
  • At least 3 months since prior stem cell transplantation or rescue without total body irradiation
  • No evidence of active graft vs host disease
  • No other concurrent anticancer biologic therapy or immunotherapy
  • Chemotherapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy
  • Endocrine therapy
  • Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days
  • Radiotherapy
  • See Biologic therapy
  • Recovered from prior radiotherapy
  • At least 6 months since prior total body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 2 weeks since prior local palliative small port radiotherapy
  • No concurrent anticancer radiotherapy
  • Surgery
  • Not specified
  • Other
  • No other concurrent investigational agents
  • No other concurrent anticancer agents
  • No other concurrent anticonvulsants
  • Patients receiving valproic acid (VPA) before study entry must have a total trough VPA concentration \< 100 mcg/mL within the past 7 days

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT00107458

    Start Date

    May 1 2005

    End Date

    March 1 2012

    Last Update

    August 7 2014

    Active Locations (17)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (17 locations)

    1

    Children's Hospital of Orange County

    Orange, California, United States, 92868

    2

    Stanford Comprehensive Cancer Center - Stanford

    Stanford, California, United States, 94305

    3

    Children's National Medical Center

    Washington D.C., District of Columbia, United States, 20010-2970

    4

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614