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GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

2014-07-23 21:12:43 | BioPortfolio

Summary

RATIONALE: GDC-0449 may be effective in treating patients with glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying how well GDC-0449 works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery.

Description

OBJECTIVES:

Primary

- Determine the 6-month progression-free survival, measured from the start of post-operative treatment with Hedgehog antagonist GDC-0449, of patients with recurrent glioblastoma multiforme (GBM).

Secondary

- Determine the toxicity of this drug in these patients.

- Determine the overall survival of these patients.

- Determine the tumor response (complete and partial) in these patients.

- Determine the in vivo drug effect on recurrent GBM and the in vivo drug effect on CD133+ glioma-derived neurospheres.

- Determine sonic Hedgehog pathway activation in primary vs recurrent GBM.

Tertiary (exploratory)

- Correlate clinical outcome (6-month progression-free survival) with the above biologic correlates.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral Hedgehog antagonist GDC-0449 once daily for 7 days before surgery.

- Arm II: Patients do not receive treatment before surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Fresh and paraffin-embedded tissue samples are collected for correlative laboratory studies.

After completion of study treatment, patients are followed up every 2 months.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

Hedgehog antagonist GDC-0449, therapeutic conventional surgery

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:43-0400

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Medical and Biotech [MESH] Definitions

Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.

A frizzled-like, G-protein-coupled receptor that associates with PATCHED RECEPTORS to transduce signals from HEDGEHOG PROTEINS and initiate hedgehog signaling to ZINC FINGER PROTEIN GLI1. It may normally inhibit signaling in the absence of SONIC HEDGEHOG PROTEIN binding to PATCHED RECEPTOR-1.

A family of intercellular signaling proteins that play and important role in regulating the development of many TISSUES and organs. Their name derives from the observation of a hedgehog-like appearance in DROSOPHILA embryos with genetic mutations that block their action.

A nicotinic cholinergic antagonist often referred to as the prototypical ganglionic blocker. It is poorly absorbed from the gastrointestinal tract and does not cross the blood-brain barrier. It has been used for a variety of therapeutic purposes including hypertension but, like the other ganglionic blockers, it has been replaced by more specific drugs for most purposes, although it is widely used a research tool.

The part of CENTRAL NERVOUS SYSTEM that is contained within the skull (CRANIUM). Arising from the NEURAL TUBE, the embryonic brain is comprised of three major parts including PROSENCEPHALON (the forebrain); MESENCEPHALON (the midbrain); and RHOMBENCEPHALON (the hindbrain). The developed brain consists of CEREBRUM; CEREBELLUM; and other structures in the BRAIN STEM.

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