Status:
COMPLETED
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Gateway for Cancer Research
Conditions:
Osteosarcoma
Nephrotoxicity
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
Brief Summary
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thi...
Detailed Description
Current osteosarcoma treatment regimens include cisplatin and high-dose methotrexate (HDMTX), which are nephrotoxic and ototoxic, and the damage to kidneys and cochlear hair cells may be irreversible....
Eligibility Criteria
Inclusion
- \<30 years of age
- histological diagnosis of high-grade osteosarcoma
- Extremity or central axis (including craniofacial) primary tumor; localized or metastatic
- No prior chemotherapy or radiation therapy for osteosarcoma. Subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTX
- Serum creatinine at or below the upper limit of normal (ULN) for age and gender
- Shortening fraction on echocardiogram \>28%
- Hearing level threshold ≤25 dB at all frequencies in both ears to be evaluable for evaluation of pantoprazole's effect on cisplatin ototoxicity. Patients with hearing loss can be enrolled but will not be evaluable for ototoxicity objective.
- Absolute neutrophil count \>1,000/microliter(mcL) and platelet count \>100,000/mcL
Exclusion
- Receiving H2 antagonists (cimetidine, ranitidine, famotidine, nizatidine) or proton pump inhibitors (lansoprazole, omeprazole, pantoprazole, esomeprazole, rabeprazole, dexlansoprazole) AND unable to hold the drug for 24 h prior to and 24 h after each cisplatin course on cycles 1-4.
- Pregnant or breastfeeding
- Unable to cooperate with research procedures
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01848457
Start Date
April 1 2013
End Date
October 1 2016
Last Update
March 16 2020
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104