Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT00838929
Phase
PHASE1
Status
Completed

Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    All doses given for 3 weeks Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd
  • Radiation Therapy — RADIATION
    Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation.

Study Details

Vorinostat in combination with radiation therapy can be administered safely and will be tolerated in patients with brain metastases, while providing an assessment of the anti-tumor activity of this combination. This is a multi-center, open-label, non-randomized Phase I study in patients with brain metastases. Patients will be administered oral Vorinostat and radiation therapy and will be treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3 subjects at each dose. If none of the three experiences a dose-limiting toxicity we will proceed to the next dose. If one of the three experiences that level of toxicity, we will accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose escalation will continue until the MTD of Vorinostat and radiation therapy is established. The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out of 6 patients).

Key Dates

Start date
Mar 31, 2009
Status verified
May 2025
Primary completion
Jan 31, 2012
Completion
Mar 31, 2015

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat (200 mg) and radiation
    Cohort 1: Patients receive 200 mg of Vorinostat and radiation
  • Experimental: Vorinostat (300 mg) and radiation
    Cohort 2: Patients receive 300 mg of vorinostat and radiation
  • Experimental: Vorinostat (400 mg) and radiation
    Cohort 3: Patients receive 400 mg of vorinostat and radiation

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases. [ Time Frame: Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
The University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Philadelphia, PA

By research site
Thomas Jefferson University· Philadelphia, PAThe University of Texas Southwestern Medical Center· Dallas, TX

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