Gary Dahl
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
TerminatedCondition(s):
Intervention(s):
- Drug: Rasburicase
Phase:
Phase 4Eligibility
Ages Eligible for Study:
Any Age to 21 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Patient is less than or equal to 21 years of age
- Patient has a diagnosis of hematologic malignancy
- Patient has hyperuricemia or is at high risk of developing hyperuricemia of malignancy
- Patient has a history of asthma or significant allergy
- No prior exposure to rasburicase or other urate oxidase
Key Exclusion Criteria:
- Pregnancy or lactation
- Wheezing or an active hypersensitivity reaction at entry
- Hypersensitivity to Aspergillus proteins
- Significant airway compression
- Known history of G6PD deficiency
Additional Study Details
Official Title:
A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma AllergiesAnticipated start date:
12/20/2005Lead Sponsor:
St. Jude ChildrenCollaborator(s):
- Sanofi-Aventis
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
SafetyPrimary Outcomes:
- Incidence of grade 3 or 4 allergic reactions
Total Number to be Enrolled:
72Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- 96148
- NCT00186940
- PEDSRASALL
- RASALL
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/9/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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