Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
NCT ID: NCT00003517
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
NCT00003516
Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
NCT00003534
Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00003533
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
NCT00170157
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
antineoplaston A10
antineoplaston AS2-1
bicalutamide
flutamide
leuprolide acetate
alternative product therapy
antiandrogen therapy
biological therapy
biologically based therapies
cancer prevention intervention
complementary and alternative therapy
differentiation therapy
endocrine therapy
hormone therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically proven localized, regional, or metastatic adenocarcinoma of the prostate
* Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy
* Measurable tumors or tumor markers
* Bone metastases allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* No hepatic failure
* Bilirubin no greater than 2.5 mg/dL
* SGOT no greater than 2 times normal
Renal:
* No chronic renal failure
* 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
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 infections or fever
* No other prior or concurrent second malignancy within the past 2 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* At least 4 weeks since prior investigational clinical trial
* No other concurrent treatment for metastatic prostate cancer
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Burzynski Research Institute
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stanislaw R. Burzynski, MD, PhD
Role: STUDY_CHAIR
Burzynski Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Burzynski Clinic
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000066560
Identifier Type: REGISTRY
Identifier Source: secondary_id
BC-PR-6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.