R(+)XK469 in Treating Patients With Advanced Neuroblastoma
Completed · Phase 1
Conditions studied: Disseminated Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma
In brief
This phase I trial is studying the side effects and best dose of R(+)XK469 in treating patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00028522
- Run by
- National Cancer Institute (NCI)
- People needed
- 85
- Starts
- 2001-12-01
- Last updated by the study team
- 2013-12-16
Who can join
Age: 5 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed high-risk neuroblastoma that has relapsed or is refractory to standard therapy
- No active brain metastases
- Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants
- Performance status - Karnofsky performance status 70-100% or Lansky score ≥ 70 for your pediatric patients
- More than 3 months
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal (unless due to documented Gilbert's syndrome)
- Creatinine less than 1.5 times upper limit of normal
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent uncontrolled illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen)
- No HIV-positive patients
- No concurrent biologic agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- No other concurrent chemotherapy
- See Disease Characteristics
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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