drugset / Trial / NCT00042367
Study of Systemic and Spinal Chemotherapy Followed by Radiation for Infants With Brain Tumors
Completed
119 enrolled
Baylor College of Medicine
Children's Hospital of Philadelphia · collabChildren's National Research Institute · collabDana-Farber Cancer Institute · collabDuke University · collabSeattle Children's Hospital · collabSt. Jude Children's Research Hospital · collabUniversity of California, San Francisco · collabUniversity of Pittsburgh · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purposes of this study are to find the highest dose of mafosfamide that can be given without causing severe side effects, to see how well the combination of these chemotherapy drugs and lower doses of radiation work to delay or stop the growth of the tumor, and to evaluate the pharmacokinetics (how the body handles) of Mafosfamide.
Timeline
- Start
- 2000-04-04
- Primary completion
- 2005-12
- Completion
- 2006-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mafosfamide | Small molecule | 14 mg | Intrathecal |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 6 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 3.5 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 30 mg/kg | Intravenous |
| Background | Etoposide | Small molecule | 1.7 mg/kg | Oral |
| Background | KCl | Unknown | — | — |
| Background | Magnesium Sulfate | Other / unclassified | — | — |
| Background | Mannitol | Diagnostic / imaging agent | 0.4 g/kg | — |
| Background | Vincristine | Small molecule | 0.05 mg/kg | Intravenous |