Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer (NCT00053118) | Clinical Trial Compass
CompletedPhase 1
Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
United States1 participantsStarted 2002-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.
Who can participate
Age range
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 primary central nervous system malignancy
* Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen
PATIENT CHARACTERISTICS:
Age
* 18 and under at initial diagnosis
Performance status
* ECOG 0-2
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count greater than 750/mm\^3
* WBC greater than 2,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect
Hepatic
* Liver function tests less than 2 times normal OR
* Absence of active hepatitis by liver biopsy
* Bilirubin less than 1.5 mg/dL
Renal
* Glomerular filtration rate greater than 60 mL/min by radionucleotide assay
Cardiovascular
* Ejection fraction at least 45%
Pulmonary
* Clinically normal pulmonary function (patients 5 years of age and under)
* FEV\_1 and FVC at least 50% (patients over 5 years of age) OR
* Arterial blood gas normal and DLCO greater than 50%
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No mucositis or mucosal infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 3 weeks since prior systemic cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 6 months since prior radiotherapy to the pelvis or spine
Surgery
* Not specified
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.