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Status:

COMPLETED

VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors

Lead Sponsor:

Pediatric Brain Tumor Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effect...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of VNP40101M in pediatric patients with recurrent, progressive, or refractory primary brain tumors. Secondary ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed\* primary brain tumor, including benign brain tumors (e.g., low-grade glioma)
  • Recurrent or progressive disease OR refractory to standard therapy NOTE: \*Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation, but must have clinical and/or radiographic evidence of disease progression
  • No bone marrow disease
  • PATIENT CHARACTERISTICS:
  • Age
  • 21 and under
  • Performance status
  • Karnofsky 50-100% (for patients \> 16 years of age) OR
  • Lansky 50-100% (for patients ≤ 16 years of age)
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,000/mm\^3\*
  • Platelet count ≥ 100,000/mm\^3\*
  • Hemoglobin ≥ 8 g/dL\* NOTE: \*Unsupported
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN
  • No overt hepatic disease
  • Renal
  • BUN \< 25 mg/dL
  • Creatinine ≤ 1.5 times ULN for age OR
  • Glomerular filtration rate \> 70 mL/min
  • No overt renal disease
  • Cardiovascular
  • Shortening fraction ≥ 30% by echocardiogram OR
  • Ejection fraction ≥ 50% by gated radionucleotide study
  • No clinically significant cardiac arrhythmia by EKG
  • No overt cardiac disease
  • Pulmonary
  • DLCO ≥ 60% of predicted
  • Chest X-ray normal (defined as absence of pulmonary infiltrates, pneumonitis, pleural effusion, pulmonary hemorrhage, or fibrosis) AND a resting pulse oximetry reading of \> 94% in room air (for patients who cannot perform the DLCO)
  • No overt pulmonary disease
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neurologic deficits allowed provided there has been no deficit progression for ≥ 1 week before study entry
  • No uncontrolled infection
  • No known hypersensitivity to polyethylene glycol
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 6 months since prior allogeneic bone marrow or stem cell transplantation
  • At least 3 months since prior autologous bone marrow or stem cell transplantation
  • More than 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
  • At least 3 weeks since prior myelosuppressive anticancer biologic therapy
  • No concurrent routine colony-stimulating factors
  • Chemotherapy
  • At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Endocrine therapy
  • Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week before study entry
  • Radiotherapy
  • At least 3 months since prior craniospinal irradiation ≥ 18 Gy
  • At least 2 weeks since prior focal irradiation to the primary tumor and/or symptomatic metastatic sites
  • Surgery
  • Not specified
  • Other
  • At least 7 days since prior nonmyelosuppressive anticancer therapy
  • At least 7 days since prior investigational agents
  • Concurrent enzyme-inducing anticonvulsant drugs allowed
  • No other concurrent anticancer or experimental agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2008

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00098761

    Start Date

    February 1 2005

    End Date

    February 1 2008

    Last Update

    June 30 2011

    Active Locations (10)

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

    Page 1 of 3 (10 locations)

    1

    UCSF Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    2

    Children's National Medical Center

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

    3

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614

    4

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115