Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT01701037
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Melanoma
  • Stage IIB Melanoma (Locally Advanced)
  • Stage IIC Melanoma (Locally Advanced)
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma (Limited, Resectable)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • dabrafenib — DRUG
    150 mg given PO
  • trametinib — DRUG
    2 mg given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well giving dabrafenib alone and in combination with trametinib before surgery works in treating patients with advanced melanoma that can be removed by surgery. Studying samples of tumor tissue in the laboratory from patients receiving dabrafenib and trametinib may help doctors learn more about the effects of these drugs on cells and help identify biomarkers that determine which patients will respond to these drugs best.

Key Dates

Start date
Jan 31, 2013
Status verified
Jun 2017
Primary completion
Feb 28, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Dabrafenib and Trametinib
    Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.

Primary Outcome Measure

Clinical Tumor Response Rate (Response is Based on Greater Than 30% Reduction From Baseline in Tumor Volume by RECIST Criteria) at Day 14. [ Time Frame: day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-

Find similar trials in Nashville, TN

By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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