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Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate


OBJECTIVES:

- Determine the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients
with stage III or IV adenocarcinoma of the prostate by determining the proportion of
patients who experience an objective 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 antineoplaston A10 and antineoplaston AS2-1
capsules 6 to 7 times a day until the maximum tolerated dose is reached. Treatment continues
for at least 3 months in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven stage III or IV adenocarcinoma of the prostate not potentially
curable by surgery or radiotherapy

- Measurable tumors or tumor markers

- No response to antiandrogen withdrawal

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT no greater than 2 times normal

- No hepatic failure

Renal:

- BUN less than 60 mg/dL

- Creatinine no greater than 2.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

- Blood ammonia normal

- No chronic renal failure

Cardiovascular:

- No severe heart disease

Pulmonary:

- No severe lung disease

Other:

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious active infection or fever

- No other concurrent serious disease

- No other prior or concurrent malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy and recovered

- Prior corticosteroids for at least 2 months allowed, but must be on stable or
decreasing dose during study participation

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery and recovered

Other:

- At least 4 weeks since prior experimental clinical trial

- No other concurrent therapy for metastatic disease

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:

CDR0000066559

NCT ID:

NCT00003516

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330