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Phase 1, Open-Label, Single-Arm, Clinical and Metabolomics Study of Dichloroacetate (DCA) in Adults With Recurrent Malignant Brain Tumors


Phase 1
21 Years
90 Years
Open (Enrolling)
Both
Brain Tumor, Glioblastoma

Thank you

Trial Information

Phase 1, Open-Label, Single-Arm, Clinical and Metabolomics Study of Dichloroacetate (DCA) in Adults With Recurrent Malignant Brain Tumors


Malignant brain tumors are defined as any World Health Organization grade III-IV glioma and
any solid tumor metastasis (spread) to the brain. Recurrent malignant brain tumors (RMBTs)
are defined as either: 1) malignant tumors, originating in the brain, that have recurred at
least once or 2) malignant tumors originating elsewhere in the body that have spread to the
brain at least once. They share an increasing incidence, clinical and radiographic
characteristics, lack of effective therapies, tendency to recur, and poor outcome.
Importantly, recurrent malignant brain tumor's shared characteristics may be usefully
exploited by an emerging class of biologic agents called metabolic modulators of which
Dichloroacetate (DCA) is the drug in the class most thoroughly investigated clinically.
DCA's mechanism of action and tolerability have been extensively demonstrated in the
treatment of chronic metabolic disorders. Furthermore, the preciseness of DCA's mechanism
of action appears to target abnormal tumor cell metabolism.


Inclusion Criteria:



- Subject must be able to consent for self. Subject must have either:

1. a brain metastasis or

2. a WHO III-IV glioma that has recurred at least once. Females of child bearing
age must have (-) pregnancy test.

- Females of child bearing age must use birth control while in study.

- Adequate organ function as determined by laboratory testing.

- Absence of peripheral neuropathy of moderate or greater severity (physician
determined).

- Greater than 4 weeks time from previous anti-neoplastic (anti-cancer) therapy.

- Subject must have a Karnofsky Performance Status (KPS) of greater than or equal to
60.

- Subject must have an ECOG performance status of less than or equal to 2.

- There are no limitations to the number of prior recurrences.

- There are no limitations to the number or types of prior therapies.

Exclusion Criteria:

- Medical contraindication for magnetic resonance imaging (MRI)testing.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety and tolerability of DCA in RMBTs.

Outcome Description:

Oral DCA will be administered until intolerance, toxicity, radiographic progression, or death. Safety and tolerance will be assessed by reviewing available standardized clinical, radiographic, and quality of life (QOL) criteria. The safety and tolerance will also be assessed by reviewing available plasma, urine, and brain tumor tissue for metabolites of the tumor and the effects of DCA thereon.

Outcome Time Frame:

Within 28 days of starting DCA +/- 3 days

Safety Issue:

Yes

Principal Investigator

Erin M. Dunbar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Food and Drug Administration

Study ID:

99-2010

NCT ID:

NCT01111097

Start Date:

April 2010

Completion Date:

March 2014

Related Keywords:

  • Brain Tumor
  • Glioblastoma
  • Brain tumors, Glioblastoma and DCA
  • Brain tumor,Glioblastoma recurrent
  • Brain Neoplasms
  • Glioblastoma

Name

Location

University of FloridaGainesville, Florida  32610-0277