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NCT00117013 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a
A Phase 1 study of Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00117013: Completed Phase 1 study of Neoplasms, sponsored by National Cancer Institute (NCI).
NCT00117013 is a Phase 1 study of Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117013, a Phase 1 study of Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional program leading to survival, angiogenesis, migration and invasion of cancer cells. We have demonstrated that chronic administration of topotecan inhibits HIF-1alpha expression, angiogenesis and tumor growth in human xenografts. Notably, the mechanism by which topotecan inhibits HIF-1alpha protein expression is independent of replication-mediated DNA damage, suggested a mechanism of action distinct from its cytotoxic effects. Objectives: This clinical trial is designed to explore the hypothesis that chronic administration of topotecan (TPT) inhibits Hypoxia Inducible factor 1alpha (HIF-1alpha) expression and angiogenesis in patients with metastatic tumors over-expressing HIF-1alpha. Eligibility: Adult patients with metastatic solid tumors expressing HIF-1alpha, for whom standard therapy does not exist or would likely not be effective, will be evaluated for study eligibility. Due to safety concerns, pregnant women and HIV-infected individuals are excluded from this study. Prior to enrollment, archival tumor tissue wil be evaluated for the expression of HIF-1alpha as assessed by IHC. Only patients who have tumors that express HIF-1alpha and who meet all eligibility criteria will be enrolled on this study. Patients will be asked to undergo a biopsy to evaluate HIF-1alpha expression before starting treatment and at the end of treatment on cycle 2 (day 12 or 13 cycle 2). Design: Topotecan at the dose of 1.2 mg/m(2) will be administered orally daily x 5 for 2 weeks, during a 28 days cycle. Imaging studies including CT, FDG-PET and DCE-MRI will be performed at baseline, at the end of treatment on cycle 1 (day 9 or 10), end of treatment on cycle 2 (day 12 or 13) and then every 2 cycles and will provide information on clinical response as well as tumor metabolism and angiogenesis. The repeat scans on day 9 or 10 of cycle 1 will be performed solely for research purp
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG Fluorine-19-Fluoroded Xyglucose
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-06-28 |
| Est. Completion | 2010-10-25 |
| Phase | Phase 1 |
What the finished NCT00117013 record still lists
NCT00117013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Topotecan is the first listed.
NCT00117013 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00117013 about?
NCT00117013 is a clinical study titled "A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a". Background: HIF-1 is a common mediator of hypoxic and non-hypoxic pathways that affects a transcriptional program leading to survival, angiogenesis, migration and invasion of cancer cells. We have demonstrated that chronic administration of topotecan inhibits HIF-1alpha expression, angiogenesis and...
What is the current status of trial NCT00117013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-06-28. Estimated completion is 2010-10-25.
What conditions does trial NCT00117013 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT00117013?
The interventions under investigation include: Topotecan (DRUG), Fluorine-19-Fluoroded Xyglucose (DRUG).
Who is sponsoring clinical trial NCT00117013?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00117013 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00117013's enrollment target sits among peer trials
16 149th of 158 higher than 10 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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