Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

Summary: RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.
  PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

Detailed description: OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed Glioblastoma Multiforme 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.
  OBJECTIVES:
  -  To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.
  -  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 glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)
  -  Measurable disease by MRI or CT scan
  -  Brain stem tumor is excluded
  -  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 2,000/mm3
  -  Platelet count at least 50,000/mm3
  Hepatic:
  -  No liver failure
  -  Bilirubin no greater than 2.5 mg/dL
  -  SGOT/SGPT no greater than 5 times upper limit
  Renal:
  -  No history of renal conditions that contraindicate high dosages of sodium
  -  Creatinine no greater than 2.5 mg/dL
  Cardiovascular:
  -  No uncontrolled hypertension
  -  No history of congestive heart failure
  -  No other cardiovascular conditions that contraindicate high dosages of sodium
  Pulmonary:
  -  No serious lung disease (e.g., severe COPD)
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use adequate contraception during and for 4 weeks after study
  -  No active infection
  -  No other serious medical or psychiatric conditions
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since immunotherapy
  -  No concurrent immunomodulating agents
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 4 weeks since chemotherapy (unless radiologically proven progression)
  -  At least 6 weeks since nitrosoureas
  Endocrine therapy:
  -  Corticosteroids allowed
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 8 weeks since radiotherapy (unless radiologically proven progression)
  Surgery:
  -  Recovered from prior surgery
  Other:
  -  No prior antineoplaston therapy
  -  Prior cytodifferentiating agent allowed

Relevance to patient case: not relevant