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NCT01010958 · ClinicalTrials.gov registry record · Phase 1
Adjuvant Valproate for High Grade Sarcomas
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01010958: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT01010958 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01010958, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
For patients initially presenting with localized sarcoma the standard of care is surgery followed by with radiation therapy (if feasible). Subsequent or adjuvant cytotoxic based chemotherapy even for aggressive sarcoma histopathologies (as commonly done for colorectal cancer or breast cancer) is controversial since over 20 individual adjuvant randomized clinical trials have not been able to consistently demonstrate a statistically significant improvement in overall survival. Maturation or differentiation therapy provides an opportunity to fundamentally change the biology of the underlying cancer (and thus its overall prognosis) by promoting cellular maturation within that cancer. A change from a poorly 'differentiated/high grade' tumor to a well 'differentiated/low grade' tumor is attainable and can change an individual's median time of survival from months to decades. The investigators have significant preclinical data that differentiation therapy using a group of drugs referred to as histone deacetylase inhibitors (such as Valproate, also a commonly used and safe anti seizure medication) is feasible for sarcomas. This approach has not been clinically addressed in solid tumors. Since adjuvant therapy is controversial for sarcomas, and building on the investigators' preclinical data, adjuvant based differentiation therapy using valproate would be predicted to be both safe and potentially extremely beneficial in terms of a) increasing the time to disease recurrence, b) improving the histology upon recurrence; and c) improving overall survival in patients with sarcomas. Patients with high grade sarcomas will receive Valproate in the adjuvant setting daily and clinically/radiologically followed until recurrence. Relapse free survival, time to local failure, time to distant failure, overall survival, and comparative histopathology of primary and recurrence will be assessed.
Primary Outcome
The primary end point will be evaluated by the 3-year recurrence rate of lower grade sarcoma histopathologically (or more well differentiated as compared to the primary tumor) amongst those who experience 3-year sarcoma recurrence.
Interventions
- DRUG Valproic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
Why NCT01010958 stopped before completion
NCT01010958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Valproic Acid is the first listed.
NCT01010958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01010958 about?
NCT01010958 is a clinical study titled "Adjuvant Valproate for High Grade Sarcomas". For patients initially presenting with localized sarcoma the standard of care is surgery followed by with radiation therapy (if feasible). Subsequent or adjuvant cytotoxic based chemotherapy even for aggressive sarcoma histopathologies (as commonly done for colorectal cancer or breast cancer) is con...
What is the current status of trial NCT01010958?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2009-10. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01010958?
The interventions under investigation include: Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT01010958?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01010958's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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