Last updated on June 2009

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Brain and Central Nervous System Tumors
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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
    DISEASE CHARACTERISTICS:
    Histologically confirmed incurable primary mixed glioma that is progressive,
    persistent, or recurrent following initial standard therapy, including radiation
    therapy
    Measurable disease by CT scan or MRI
    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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.