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NCT01848457 · ClinicalTrials.gov registry record · Phase 2
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
A Phase 2 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01848457: Completed Phase 2 study, sponsored by Children's Hospital of Philadelphia.
NCT01848457 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848457, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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-thirds patients with osteosarcoma, but the treatment can also cause irreversible damage to the kidneys and cause permanent hearing loss. The purpose of this study is to evaluate new approaches to prevent these side effects without interfering with the beneficial effects of the chemotherapy drugs on the cancer by using our knowledge of how the drugs damage the kidney and cochlear hair cells in the ear to selectively block these side effects. Preventing these side effects without interfering with the anti-cancer effect of the drugs will improve the outcome in survivors and may also improve the effectiveness of the chemotherapy regimen by preventing treatment delays and dose reductions that are often caused by the side effects. Patients will be carefully monitored to ensure that the new interventions do not adversely affect response to the treatment and do not increase the other side effects of the chemotherapy. Specifically, we will monitor the nutritional status of the patients closely and ask patients to complete a survey describing the side effects after each treatment cycle. We will also collect a small sample of cancer tissue at the time of biopsy and surgery from each patient on this study for testing to determine new classes of anti-cancer drugs currently under development may have a role in treating osteosarcoma. If effective, these new approaches to prevent kidney damage and hearing loss will be applicable in other types of cancers treated with the same chemotherapy drugs.
Primary Outcome
This measure describes the urinary biomarkers of AKI after each course of C throughout Cycles 1-2, compared to baseline (pre-infusion) values. Biomarkers of AKI, include: Kidney Injury Molecule-1 (KIM-1), and Neutrophil Gelatinase-Associated Lipocalin (NGAL).
Interventions
- DRUG Pantoprazole
- DRUG High-dose methotrexate infusion duration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-10-01 |
| Phase | Phase 2 |
What the finished NCT01848457 record still lists
NCT01848457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Pantoprazole is the first listed.
NCT01848457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01848457 about?
NCT01848457 is a clinical study titled "Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy". 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-thirds patients with osteosarcoma, but the treatment can also cause irreversible damage to the kidneys ...
What is the current status of trial NCT01848457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2013-04. Estimated completion is 2016-10-01.
What interventions are being tested in trial NCT01848457?
The interventions under investigation include: Pantoprazole (DRUG), High-dose methotrexate infusion duration (DRUG).
Who is sponsoring clinical trial NCT01848457?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01848457's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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