Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children W… (NCT00238173) | Clinical Trial Compass
TerminatedPhase 1
Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors
Stopped: OHSU IRB closed study to further enrollment 2/17/2006
United States2 participantsStarted 2004-12
Plain-language 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 stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Mannitol may help chemotherapy work better by making it easier for these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may be an effective treatment for malignant brain tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating children with malignant brain tumors.
Who can participate
Age range
1 Year – 18 Years
Sex
ALL
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 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess toxicity and the maximally tolerated dose of N-acetylcysteine administered in conjunction with carboplatin, cyclophosphamide and etoposide phosphate BBBD, and delayed high dose sodium thiosulfate, in children with malignant brain tumors.