BIBF 1120 for Recurrent High-Grade Gliomas
Condition: Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma
MeSH terms: Glioblastoma; Astrocytoma; Gliosarcoma; Oligodendroglioma
Intervention: BIBF 1120
Intervention description: 200 mg BID oral for 28 day cycle
Intervention MeSH terms: Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: brain tumor; recurrent disease

Summary:

      BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally.
      This drug is currently being used in treatment for other cancers in research studies and
      information from those other research studies suggests that this agent, BIBF 1120, may help
      to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth
      of new blood vessels at the site of the tumor. In this research study, the investigators are
      looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically-confirmed, supratentorial, recurrent glioblastoma; subjects with
             an initial diagnosis of a lower grade glioma are eligible if a subsequent biopsy is
             determined to be glioblastoma

          -  Demonstration of recurrent disease on MRI following prior therapy

          -  Development of progressive disease after having received prior RT, and must have an
             interval of at least 12 weeks from the completion of any radiation therapy to study
             entry (unless progressive tumor growth is outside the radiation field or there is
             histopathological confirmation of recurrent tumor).

          -  Bi-dimensionally measurable disease (minimum measurement of 1 cm in one dimension) on
             MRI performed within 14 days prior to first treatment. (If receiving corticosteroids,
             participants must be on a stable or decreasing dose of corticosteroids for at least 5
             days prior to baseline MRI.)

          -  Life expectancy of at least 12 weeks

          -  KPS >/= 60

          -  Normal organ and marrow function as defined by protocol

          -  Recovered from toxic effects of prior therapy

          -  Sufficient tumor availability (at least 15-20 unstained paraffin slides from any prior
             surgery)

        Exclusion Criteria:

          -  Receiving other investigational agent

          -  More than 2 prior relapses

          -  Prior therapy with inhibitor of VEGF, VEGFR, PDGFR, or FGFR (including bevacizumab)

          -  Pregnant or breast-feeding

          -  Unwilling to agree to adequate contraception, if subject is of child-bearing potential

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to BIBF 1120

          -  Use of EIAEDs within 14 days of registration

          -  Evidence of recent hemorrhage on baseline MRI of the brain

          -  Uncontrolled intercurrent illness

          -  Uncontrolled hypertension

          -  History of hypertensive encephalopathy

          -  History of any of the following within 6 months prior to enrollment: myocardial
             infarction or unstable angina, stroke or transient ischemic attack, significant
             vascular disease or peripheral arterial thrombosis, abdominal fistula,
             gastrointestinal perforation, or intra-abdominal abcess, intracerebral abscess

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks
             prior to the first treatment day, or anticipation of need for major surgical procedure
             during the course of the study

          -  Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy
             within 7 days prior to the first treatment day

          -  Serious non-healing wound, ulcer, or bone fracture

          -  History of a different malignancy unless disease-free for at least 5 years (unless
             cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin)

          -  HIV positive