Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Antineoplaston Therapy in Treating Patients With Advanced Head and Neck 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 advanced head and neck cancer.

Detailed description: OBJECTIVES:
  -  Provide treatment with antineoplastons A10 and AS2-1 to patients with incurable cancer of the head and neck.
  -  Describe response to, tolerance to, and side effects of this regimen in these patients.
  OUTLINE: This is an open-label study.
  Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection six times per day until the maximum tolerated dose is reached.
  Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for 8 months beyond 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 cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists
  -  Metastatic disease OR incurable with surgery or radiation
  -  Measurable disease by CT scan or MRI
  -  Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas
  PATIENT CHARACTERISTICS:
  Age:
  -  16 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 2.5 mg/dL
  Renal:
  -  No renal insufficiency
  -  Creatinine no greater than 2.5 mg/dL
  -  No renal conditions that contraindicate high dosages of sodium
  Cardiovascular:
  -  No chronic heart failure
  -  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 chronic obstructive pulmonary disease)
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 4 weeks after study participation
  -  No other serious medical or psychiatric conditions
  -  No active infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior immunotherapy and recovered
  -  No concurrent immunomodulatory 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 (unless multiple tumors) and recovered
  Surgery:
  -  See Disease Characteristics
  Other:
  -  Prior cytodifferentiating agents allowed

Relevance to patient case: not relevant