Status:
TERMINATED
Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bone Marrow Suppression
Brain and Central Nervous System Tumors
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopp...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity and maximum tolerated dose of acetylcysteine when given in combination with blood-brain barrier disruption treatment with mannitol, combination chemother...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed brain tumors, including any of the following:
- Brain stem glioma
- Primitive neuroectodermal tumor
- CNS germ cell tumor
- Malignant glioma
- Diagnosis based on any of the following:
- CT-assisted or stereotactic biopsy
- Open biopsy
- Surgical resection
- Cerebrospinal fluid cytology
- Elevated tumor markers
- Unequivocal radiographic changes (for patients with brain stem glioma or optic glioma)
- All tumor types, except brain stem glioma, must be recurrent
- No radiographic signs of intracranial herniation and/or spinal cord block
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-2
- Life expectancy
- At least 90 days
- Hematopoietic
- WBC ≥ 2,500/mm\^3
- Absolute granulocyte count ≥ 1,200/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- SGOT and SGPT \< 2.5 times upper limit of normal
- Bilirubin \< 2.0 mg/dL
- Renal
- Creatinine \< 1.8 mg/dL
- Pulmonary
- No history of clinically significant reactive airway disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant risk for general anesthesia
- No uncontrolled, clinically significant, confounding medical condition within the past 30 days
- No contraindication to study drugs
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- At least 28 days since prior systemic chemotherapy
- Radiotherapy
- At least 3 months since prior total spine radiotherapy
- At least 14 days since prior cranial radiotherapy
- Prior systemic radiotherapy allowed
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2006
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00238173
Start Date
December 1 2004
End Date
February 17 2006
Last Update
April 21 2017
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098