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Antineoplaston Therapy in Treating Patients With Colon Cancer

Sponsor
Burzynski Research Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00003486
Collaborator
(none)
0
Enrollment
1
Location

Study Details

Study Description

Brief 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 is studying how well antineoplaston therapy works in treating patients with colon cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
  • Procedure: alternative product therapy
  • Procedure: biological therapy
  • Procedure: biologically based therapies
  • Procedure: cancer prevention intervention
  • Procedure: complementary and alternative therapy
  • Procedure: differentiation therapy
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Burzynski Clinic Houston Texas United States 77055-6330

    Sponsors and Collaborators

    • Burzynski Research Institute

    Investigators

    • Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003486
    Other Study ID Numbers:
    • BC-CO-3
    • CDR0000066524
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Dec 1, 2006
    Additional relevant MeSH terms:
    Adenocarcinoma
    Colonic Neoplasms

    Study Results

    No Results Posted as of Jul 10, 2013