Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

Summary: RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
  PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating children with recurrent or refractory high grade glioma.

Detailed description: OBJECTIVES:
  -  Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with high-grade glioma by determining the proportion of patients who experience an objective tumor response.
  -  Evaluate the adverse effects of and tolerance to this regimen in these patients.
  OUTLINE: This is an open-label study.
  Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of unacceptable toxicity or disease progression. After 12 months, patients with responding or stable disease may continue treatment.
  Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed incurable high-grade glioma, glioblastoma multiforme, or anaplastic astrocytoma that is refractory or recurrent, or with residual tumor after standard therapy, including radiotherapy
  -  Evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan
  -  No brain stem tumor
  PATIENT CHARACTERISTICS:
  Age:
  -  6 months to 17 years
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  WBC greater than 1,500/mm^3
  -  Platelet count greater than 50,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 2.5 mg/dL
  -  SGOT/SGPT no greater than 5 times upper limit of normal
  -  No hepatic failure
  Renal:
  -  Creatinine no greater than 2.5 mg/dL
  -  No renal insufficiency
  Cardiovascular:
  -  No severe heart disease
  -  No uncontrolled hypertension
  -  No history of congestive heart failure
  Pulmonary:
  -  No severe lung disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 4 weeks after study participation
  -  No serious active infections or fever
  -  No other serious concurrent disease
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior immunotherapy and recovered
  -  No concurrent immunomodulating agents
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  -  No concurrent antineoplastic therapy
  Endocrine therapy:
  -  Concurrent corticosteroids allowed
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 8 weeks since prior radiotherapy and recovered
  Surgery:
  -  Not specified
  Other:
  -  No prior antineoplaston therapy

Relevance to patient case: not relevant