Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
Condition: Glioblastoma Multiforme of the Brain
MeSH terms: Glioblastoma
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: adult glioblastoma; recurrent glioblastoma

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.
    

Eligibility criteria:

        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