Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer

Summary: Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of metastatic or unresectable Colon Cancer.
  PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer

Detailed description: OVERVIEW: This is a single arm, open-label study in which patients with metastatic or unresectable Colon Cancer cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
  OBJECTIVES:
  -  To determine the efficacy of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
  -  To determine the safety and tolerance of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer.
  -  To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists
  -  Metastatic or unresectable disease
  -  Measurable disease by CT scan or MRI
  PATIENT CHARACTERISTICS:
  Age:
  -  18 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:
  -  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 failure
  -  No history of renal conditions that contraindicate high dosages of sodium
  Cardiovascular:
  -  No 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 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 other serious concurrent disease
  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 agents
  Endocrine therapy:
  -  Concurrent corticosteroids allowed
  Radiotherapy:
  -  At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier)
  Surgery:
  -  Recovered from prior surgery
  Other:
  -  Prior cytodifferentiating agent allowed
  -  No prior antineoplaston therapy

Relevance to patient case: not relevant