Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

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 refractory stage IV prostate cancer.

Detailed description: OBJECTIVES:
  -  Provide treatment with intravenous antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of the prostate who failed to respond to treatment with antineoplaston A10 and AS2-1 capsules.
  -  Describe response to, tolerance to, and side effects of this regimen in these patients.
  OUTLINE: This is an open-label study.
  Patients receive gradually increasing doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
  Treatment continues for at least 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: A total of 20-40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists
  -  Evidence of tumor by MRI or CT scan
  -  No prostate-specific antigen (PSA) response to antiandrogen withdrawal
  -  If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Hemoglobin at least 9 g/dL
  -  WBC at least 2000/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:
  -  Creatinine no greater than 2.5 mg/dL
  -  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 history of other cardiovascular conditions that contraindicate high dosages of sodium
  Pulmonary:
  -  No serious lung disease, such as severe chronic obstructive pulmonary disease
  Other:
  -  Fertile patients must use effective contraception during and for 4 weeks after study participation
  -  Not a high medical or psychiatric risk
  -  No concurrent nonmalignant systemic disease that would preclude therapy
  -  No active infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior immunotherapy and recovered
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy and recovered
  Endocrine therapy:
  -  See Disease Characteristics
  -  At least 4 weeks since prior hormonal therapy and recovered
  -  Concurrent corticosteroids allowed if dose is stable or decreasing
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy and recovered
  Surgery:
  -  Recovered from prior surgery
  Other:
  -  Prior cytodifferentiating agents allowed

Relevance to patient case: not relevant