Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

Summary: RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with recurrent or refractory mixed gliomas.
  PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

Detailed description: OBJECTIVES:
  -  To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas as measured by an objective response to therapy (complete response, partial response or stable disease).
  -  To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas.
  OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory mixed gliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.
  To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
  PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy
  -  Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry
  -  Must have received and failed standard therapy
  -  Tumor must be at least 5 mm
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  WBC at least 2000/mm3
  -  Platelet count at least 50,000/mm3
  Hepatic:
  -  No hepatic insufficiency
  -  Bilirubin no greater than 2.5 mg/mL
  -  SGOT and SGPT no greater than 5 times upper limit of normal
  Renal:
  -  No renal insufficiency
  -  Creatinine no greater than 2.5 mg/mL
  -  No history of renal conditions that contraindicate high dosages of sodium
  Cardiovascular:
  -  No known chronic heart failure
  -  No uncontrolled hypertension
  -  No history of congestive heart failure
  -  No other cardiovascular conditions that contraindicate high dosages of sodium
  Pulmonary:
  -  No severe lung disease
  -  No severe chronic obstructive pulmonary disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 4 weeks after study
  -  No other severe medical illness
  -  No nonmalignant systemic disease
  -  No active infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since immunotherapy
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  Endocrine therapy:
  -  Concurrent corticosteroids allowed
  Radiotherapy:
  -  At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression)
  Surgery:
  -  Fully recovered from prior surgery
  Other:
  -  Prior cytodifferentiating agent allowed
  -  No prior antineoplaston therapy

Relevance to patient case: not relevant