Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors

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 studies the effectiveness of antineoplaston therapy in treating patients who have metastatic, recurrent, or refractory primitive neuroectodermal tumors.

Detailed description: OBJECTIVES:
  -  Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable primitive neuroectodermal tumors outside the central nervous system.
  -  Describe response, tolerance to, and side effects of this regimen in these patients.
  OUTLINE: This is an open-label study.
  Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
  Treatment continues for 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
  Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
  PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed incurable primitive neuroectodermal tumors outside the central nervous system that are unlikely to respond to existing therapy, meeting 1 of the following criteria:
  -  Metastatic disease
  -  Progressive, recurrent, or refractory disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy
  -  Measurable disease by MRI or CT scan
  -  Tumor must be at least 2 cm
  PATIENT CHARACTERISTICS:
  Age:
  -  6 months and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  WBC at least 2,000/mm^3
  -  Platelet count at least 50,000/mm^3
  Hepatic:
  -  No hepatic insufficiency
  -  Bilirubin no greater than 2.5 mg/dL
  -  SGOT and SGPT no greater than 5 times upper limit of normal
  Renal:
  -  No renal insufficiency
  -  Creatinine no greater than 2.5 mg/dL
  -  No history of renal conditions that contraindicate high dosages of sodium
  Cardiovascular:
  -  No uncontrolled hypertension
  -  No history of congestive heart failure
  -  No history of other cardiovascular conditions that contraindicate high dosages of sodium
  Pulmonary:
  -  No serious lung disease, such as chronic obstructive pulmonary disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 4 weeks after study participation
  -  No active infection
  -  No nonmalignant systemic disease
  -  Not a high medical or psychiatric risk
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior immunotherapy
  -  No concurrent immunomodulating agents
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  Endocrine therapy:
  -  Concurrent corticosteroids allowed
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 8 weeks since prior radiotherapy
  Surgery:
  -  See Disease Characteristics
  -  Recovered from prior surgery
  Other:
  -  Prior cytodifferentiating agents allowed
  -  No prior antineoplastons
  -  No other concurrent antineoplastic agents

Relevance to patient case: not relevant