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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pediatric Brain Tumor Consortium
• Collaborator: National Cancer Institute (NCI)

Criteria

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