VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors (NCT00098761) | Clinical Trial Compass
CompletedPhase 1
VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors
United States42 participantsStarted 2005-02
Plain-language 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 effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* N…
What they're measuring
1
Estimate the maximum tolerated dose
Timeframe: First 6 weeks of therapy
2
Number of participants with dose limiting toxicities