- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003516
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate
Current therapies for Stage III or 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 Stage III or Stage IV Prostate Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stage III or Stage IV Prostate Cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Stage III or 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 Stage III or Stage IV Prostate Cancer.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77055-6330
- Burzynski Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antineoplastons
Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day.
Treatment continues in the absence of disease progression or unacceptable toxicity.
absence of disease progression or unacceptable toxicity.
|
Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day.
Treatment continues in the absence of disease progression or unacceptable toxicity.
absence of disease progression or unacceptable toxicity.
Other Names:
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066559
- BC-PR-5 (Other Identifier: Burzynski Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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