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Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer


Phase 2
14 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, 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:

CDR0000066577

NCT ID:

NCT00003530

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Liver Cancer
  • stage IV childhood liver cancer
  • recurrent childhood liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330