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NCT00701688 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1 study of Hematopoietic Stem Cell Transplantation and Oral Mucositis, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00701688: Completed Phase 1 study of Hematopoietic Stem Cell Transplantation and Oral Mucositis, sponsored by St. Jude Children's Research Hospital.
NCT00701688 is a Phase 1 study of Hematopoietic Stem Cell Transplantation and Oral Mucositis that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants, below the 9,789-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00701688, a Phase 1 study of Hematopoietic Stem Cell Transplantation and Oral Mucositis, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition and intravenous narcotics for pain control. Palifermin (Kepivance\[TM\]) is a human keratinocyte growth factor that is produced by recombinant DNA technology in E. coli. Palifermin is a FDA-approved, commercially available pharmacologic agent that is manufactured by Amgen. As keratinocyte growth factor receptors have been found within the epithelium of gastric mucosa, the use of palifermin has been proven to decrease the frequency and duration of severe mucositis in adult studies. Whereas the appropriate dosing regimen has been determined for adults at 60mcg/kg/day, the dosing of palifermin has not been established in the pediatric setting. This initial pediatric study of palifermin will determine the maximum tolerated dose, evaluating the use of this agent at three dose levels, below, at, and above the recommended adult dose. Non-hematologic, life-threatening NCI grade IV or grade V toxicities definitely related to the administration of palifermin from the first infusion until day +6 after HSCT (post palifermin administration day +3) will comprise the safety endpoints of the study. The study is designed to evaluate palifermin at 3 dose levels. The study population will be recipients of either a matched family member donor or matched unrelated donor HSCT. The pharmacokinetics of palifermin at each dose level will be described to help determine the appropriate dose for future studies, which will evaluate efficacy
Conditions Studied
Interventions
- DRUG Palifermin
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00701688 record still lists
NCT00701688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 9,789-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Palifermin is the first listed.
NCT00701688 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00701688 about?
NCT00701688 is a clinical study titled "Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation". Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition and intravenous narcotics for pain control. Palifermin (Kepivance\[TM\]) is a human keratinocyte growth factor that ...
What is the current status of trial NCT00701688?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2007-09. Estimated completion is 2012-02.
What conditions does trial NCT00701688 study?
This clinical trial studies the following conditions: Hematopoietic Stem Cell Transplantation, Oral Mucositis.
What interventions are being tested in trial NCT00701688?
The interventions under investigation include: Palifermin (DRUG).
Who is sponsoring clinical trial NCT00701688?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00701688 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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