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Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Colon Cancer, Recurrent Colon Cancer, Adenocarcinoma of the Colon

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
adenocarcinoma of the colon 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 oral antineoplaston A10 and oral
antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete
response after 3-4 months of treatment, the investigator may discontinue treatment. Patients
with stable disease may continue to receive treatment until disease progression or
unacceptable toxicity is observed.

Tumors are measured every 4 months during the first 2 years, then every 6 months during
years 3 and 4, and yearly during years 5 and 6.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to
existing therapy and for which no curative therapy exists

- Measurable disease by MRI or CT scan

- Metastatic or unresectable disease

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

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

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 serious malabsorption syndromes

- No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered (patients with multiple
tumors may be admitted earlier)

Surgery:

- No prior extensive stomach or intestinal surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066524

NCT ID:

NCT00003486

Start Date:

Completion Date:

Related Keywords:

  • Stage IV Colon Cancer
  • Recurrent Colon Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330