- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003533
Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate
Current therapies for Metastatic Pancreatic 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 Metastatic Pancreatic Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic Pancreatic Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Metastatic Pancreatic 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 Metastatic Pancreatic 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 Metastatic Pancreatic 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.
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 incurable, metastatic, hormone-refractory adenocarcinoma of the prostate that is unlikely to respond to existing therapy
- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
- Stage D2
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 2,000/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
- 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:
- At least 4 weeks since prior hormonal therapy (unless progression documented upon discontinuation of hormones)
- Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months before study entry
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agent allowed
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: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months.
Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
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Patients with Metastatic Pancreatic 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.
Other Names:
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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
- CDR0000066580
- BC-PR-4 (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.
Clinical Trials on Metastatic Prostate Cancer
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Imperial College LondonWellcome Trust; Imperial Clinical Trials Unit (ICTU)CompletedProstate Cancer | Metastatic Prostate Cancer | Prostate Adenocarcinoma | Prostate Cancer Metastatic | Metastatic Prostate Carcinoma in the Soft Tissue | Non-metastatic Prostate CancerUnited Kingdom
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The University of Texas Health Science Center at...WithdrawnMetastatic Prostate Cancer | Prostate Cancer Metastatic | Metastatic Prostate Adenocarcinoma | Castrate Resistant Prostate CancerUnited States
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Dana MathewsWithdrawnProstate Cancer | Prostate Cancer Metastatic | Prostate Cancer Metastatic to BoneUnited States
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Herlev and Gentofte HospitalBristol-Myers SquibbRecruitingProstate Cancer Metastatic | Metastatic Castration-resistant Prostate Cancer | Castrate Resistant Prostate Cancer | Prostate Cancer Stage IVDenmark
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Myovant Sciences GmbHRecruitingMetastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate CancerUnited States
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Bellicum PharmaceuticalsSuspendedMetastatic Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
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Dana-Farber Cancer InstituteEpizyme, Inc.; PfizerRecruitingMetastatic Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
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Tavanta TherapeuticsCompletedMetastatic Prostate Cancer | Metastatic Castration-sensitive Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States, Spain, United Kingdom, Hungary, France, Poland, Puerto Rico, Sweden
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Memorial Sloan Kettering Cancer CenterProgenics Pharmaceuticals, Inc.RecruitingProstate Cancer | Metastatic Prostate Cancer | Prostate Adenocarcinoma | Prostate Cancer Metastatic | Prostate NeoplasmUnited States
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Vadim S KoshkinEli Lilly and Company; Prostate Cancer FoundationActive, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Metastatic Castration-resistant Prostate Cancer | Metastatic Prostate Adenocarcinoma | Metastatic Castration-resistant Prostate CarcinomaUnited States
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