Clinical trial · Interventional
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer
NCT00946673CI-TRIAL-00029803completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer (NSCLCA) brain metastases in patient with 1-4 lesions.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Procedure | — | UNRESOLVED |
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vorinostat & stereotactic radiosurgery
- interventionNames
- Drug: Vorinostat
- Procedure: Radiation Therapy
Primary outcomes (3)
- measure
- The maximum tolerated dose of vorinostat with concurrent radiosurgery will be determined.
- timeFrame
- 30 days following Stereotactic Radiosurgery
- measure
- During the expanded phase I portion of the study, the safety of the Maximum tolerated dose dose will be confirmed.
- timeFrame
- 30 days following Stereotactic Radiosurgery
- measure
- The radiologic response, defined as local control and distant intra-cranial control rates at 3-months following radiotherapy, will be determined.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation. * Adequate organ function (section 3.1.10). * ECOG performance status 0-2. * Life expectancy of \>=12 weeks. * Systemic chemotherapy washout period \>=7 days. Exclusion Criteria: Patients who have previously been treated with whole brain irradiation, pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.