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Antineoplaston Therapy in Treating Patients With Colon Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003486
First Posted: January 27, 2003
Last Update Posted: July 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Stage IV Colon Cancer Recurrent Colon Cancer Adenocarcinoma of the Colon 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

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

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 0
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003486


Locations
United States, Texas
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
  More Information

ClinicalTrials.gov Identifier: NCT00003486     History of Changes
Other Study ID Numbers: BC-CO-3
CDR0000066524 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: July 10, 2013
Last Verified: December 2006

Additional relevant MeSH terms:
Adenocarcinoma
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases


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