Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenograstim; Sargramostim; Topotecan

Criteria

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