Spots Global Cancer Trial Database for Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma
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Trial Identification
Brief Title: Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma
Official Title: A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Adults With Recurrent or Refractory Medulloblastoma
Study ID: NCT00939484
Conditions
Study Description
Brief Summary: This phase II trial is studying how well vismodegib works in treating adult patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and may be an effective treatment for medulloblastoma.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the efficacy of GDC-0449 (vismodegib) treatment for adult patients with recurrent or refractory medulloblastoma, as measured by the objective response rates for patients without (Stratum A) and with (Stratum B) evidence of activation of Sonic Hedgehog (SHH) signaling pathway tumors. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of GDC-0449 administered on a once daily schedule. II. To estimate the duration of objective response and progression-free survival (PFS). III. To characterize the pharmacokinetics (plasma and cerebrospinal fluid) of GDC-0449 in adults with refractory medulloblastoma. IV. To document pathologic and genomic methods to identify CNS tumors with activation of the PTCH/SHH pathway. V. To describe the objective responses observed in patients whose pathologic assessment of tumor result in unknown (Stratum C) evidence of activation of Sonic Hedgehog (SHH) signaling pathway tumors. OUTLINE: This is a multicenter study. Patients are stratified according to PTCH/Sonic Hedgehog signaling pathway activation (inactivated vs activated vs unknown). Patients receive vismodegib orally (PO) once daily on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 12 months.
Keywords
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Pediatric Brain Tumor Consortium, Memphis, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Baylor College of Medicine, Houston, Texas, United States
Contact Details
Name: Amar Gajjar
Affiliation: Pediatric Brain Tumor Consortium
Role: PRINCIPAL_INVESTIGATOR
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