Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003530
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2004
  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 studies the effectiveness of antineoplaston therapy in treating patients who have primary liver cancer.


Condition Intervention Phase
Liver Cancer
Drug: antineoplaston A10
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer

Resource links provided by NLM:


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

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:

OBJECTIVES:

  • Determine the response, tolerance to, and side effects of antineoplaston A10 in patients with incurable primary liver cancer.

OUTLINE: This is an open label study.

Patients receive gradually increasing doses of antineoplaston A10 by arterial infusion daily until the final dose level is reached.

Therapy continues for at least 2 months in the absence of unacceptable toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 2 months after reaching CR.

Tumors are measured every month for the first 2 months, every 2 months for the first year, and every 3 months for the second year.

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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Measurable disease by CT scan or MRI
  • Tumor must be at least 2 cm

PATIENT CHARACTERISTICS:

Age:

  • 14 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2,000/mm3
  • Platelet count at least 50,000/mm3

Hepatic:

  • Bilirubin less than 3 mg/dL
  • SGOT/SGPT no greater than 10 times upper limit of normal
  • No hepatic failure

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high doses of sodium

Cardiovascular:

  • No uncontrolled hypertension
  • No known chronic heart failure
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high doses of sodium

Pulmonary:

  • No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study
  • No serious medical or psychiatric disease
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Recovered from prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agents allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003530

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003530     History of Changes
Other Study ID Numbers: CDR0000066577, BC-HE-2
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV childhood liver cancer
recurrent childhood liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 15, 2014