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Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
Not Recruiting
Trial ID: NCT00107471
Purpose
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in
bone marrow or peripheral blood and may help the immune system recover from the side effects
of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan may
make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF together
with radiation therapy may be an effective treatment for brain stem glioma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when
given together with G-CSF and radiation therapy and to see how well they work in treating
young patients with newly diagnosed brain stem glioma.
Official Title
A Phase I/II Study of Topotecan With G-CSF and Radiation Therapy in Children With Malignant Intrinsic Pontine Brainstem Gliomas of Childhood
Stanford Investigator(s)
Eligibility
DISEASE CHARACTERISTICS:
- Diagnosis of intrinsic pontine brain stem glioma within the past 30 days
- Histologic confirmation not required provided the tumor has a pontine epicenter
AND exhibits diffuse (rather than focal) involvement of ≥ 2/3 of the pons with or
without extension to the adjacent medulla or midbrain* NOTE: *Brain stem tumors
that do not meet these criteria must be histologically confirmed as grade III or
IV malignant glioma
- Measurable disease by radiographic imaging
- Post-operative MRI required within the past 30 days if patient had a biopsy or
surgical resection
- No disseminated disease
- No neurofibromatosis type 1
PATIENT CHARACTERISTICS:
Age
- 3 to 21 at diagnosis
Performance status
- Lansky 50-100% OR
- Karnofsky 50-100%
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT < 2.5 times ULN
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
- Not severely somnolent or comatose
- Central cortical neurotoxicity scale < grade 3
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunomodulating agents
Chemotherapy
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Concurrent corticosteroids allowed for neurological deficits related to the tumor
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
- Prior biopsy or surgical resection for malignant brain stem glioma allowed
Other
- No other prior therapy for malignant brain stem glioma
Intervention(s):
radiation: radiation therapy
biological: filgrastim
drug: topotecan hydrochloride
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507364281