Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

Stage IV Prostate Cancer Clinical Trial

Official title:

Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003534
• Other study ID #: CDR0000066581
• Secondary ID: BC-PR-8
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 29, 2018
• Start date: October 11, 1996
• Est. completion date: February 20, 1997

Study information

• Verified date: January 2018
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for Refractory Stage IV Prostate Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory Stage IV Prostate Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory Stage IV Prostate Cancer.

Description:

Refractory Stage IV Prostate Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with Refractory Stage IV Prostate Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).

• To determine the safety and tolerance of Antineoplaston therapy in patients with Refractory Stage IV Prostate Cancer.

• To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 20, 1997
• Est. primary completion date: February 20, 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists

• Evidence of tumor by MRI or CT scan

• No prostate-specific antigen (PSA) response to antiandrogen withdrawal

• If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Hemoglobin at least 9 g/dL

• WBC at least 2000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic:

• No hepatic insufficiency

• Bilirubin no greater than 2.5 mg/dL

• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No known chronic heart failure

• No uncontrolled hypertension

• No history of congestive heart failure

• No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

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

• Not a high medical or psychiatric risk

• No concurrent nonmalignant systemic disease that would preclude therapy

• No active infection

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:

• See Disease Characteristics

• At least 4 weeks since prior hormonal therapy and recovered

• Concurrent corticosteroids allowed if dose is stable or decreasing

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage IV Prostate Cancer

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients With Refractory Stage IV Prostate Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute