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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 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 response to, tolerance to, and side effects of this regimen in these
patients.

OUTLINE: Patients receive gradually escalating 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 12 months in the absence of disease
progression. Patients achieving complete response (CR) continue treatment for at least 8
months after reaching CR.

Tumors are measured at least 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.

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

- 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

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:

CDR0000066523

NCT ID:

NCT00003485

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • adenocarcinoma of the colon
  • Adenocarcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330