Aflibercept, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma Multiforme, Gliosarcoma, or Other Malignant Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00650923
Phase
PHASE1
Status
Completed

Conditions

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • ziv-aflibercept — DRUG
    Given IV
  • radiation therapy — PROCEDURE
    Undergo RT
  • temozolomide — DRUG
    Given PO
  • pharmacological study — PROCEDURE
    Correlative studies
  • laboratory biomarker analysis — PROCEDURE
    Correlative studies

Study Details

This phase I trial is studying the side effects and best dose of aflibercept when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or recurrent glioblastoma multiforme, gliosarcoma, or other malignant glioma. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with radiation therapy and temozolomide may kill more tumor cells.

Key Dates

Start date
Jul 31, 2008
Status verified
Apr 2014
Primary completion
Jun 30, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    See Detailed Description

Primary Outcome Measure

Maximum tolerated dose of aflibercept defined as the dose at which fewer than one-third of patients experience DLT based on the CTC severity grading [ Time Frame: 28 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California at Los Angeles (UCLA )Los AngelesCalifornia90095-
UCSF-Mount ZionSan FranciscoCalifornia94115-
University of California San Francisco Medical Center-ParnassusSan FranciscoCalifornia94143-
Adult Brain Tumor ConsortiumBaltimoreMaryland21231-1000-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalCharlestownMassachusetts02129-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
University of PittsburghPittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
University of California at Los Angeles (UCLA )· Los Angeles, CAUCSF-Mount Zion· San Francisco, CAUniversity of California San Francisco Medical Center-Parnassus· San Francisco, CAAdult Brain Tumor Consortium· Baltimore, MDDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Charlestown, MA

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