- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003452
Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Current therapies for Stage IV bladder 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 IV bladder cancer
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV bladder cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stage IV bladder 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 Stage IV bladder 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 IV bladder 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
Inclusion Criteria:
- Histologically confirmed stage IV bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists or stage IV newly diagnosed, incurable bladder carcinoma
- Measurable disease by CT scan
- Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
- 18 and over
- Karnofsky 60-100%
- Life expectancy: greater than 2 months
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
- No severe lung disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No serious active infections or fever
- No other serious concurrent disease
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from any prior operative procedure
- Prior cytodifferentiating agent allowed
Exclusion Criteria:
- Prior antineoplaston therapy
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 |
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Experimental: Antineoplastons
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 Stage IV Bladder 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
- CDR0000066483
- BC-BL-02 (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 Stage IV Bladder Cancer
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H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
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NRG OncologyNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder CancerCanada, United States, Israel
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Zhujiang HospitalGuangdong Xiangxue Precision Medical Technology Co., Ltd.; Xiangxue Life Science... and other collaboratorsCompletedSolid Tumor | Breast Cancer Stage IV | Gastric Cancer Stage IV | Ovarian Cancer Stage IV | Liver Cancer Stage IV | Esophageal Cancer, Stage IV | Bone and Soft Tissue Tumors | Bladder Carcinoma Stage IV | Prostate Carcinoma Stage IV | Thyroid Cancer Stage IVChina
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National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Renal Pelvis Cancer AJCC v8 | Stage IV Ureter Cancer... and other conditionsUnited States
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National Cancer Institute (NCI)Active, not recruitingAdvanced Bladder Urothelial Carcinoma | Advanced Ureter Urothelial Carcinoma | Metastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Stage III Bladder Cancer AJCC v8 | Stage III... and other conditionsUnited States, Canada
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National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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University of ChicagoNational Cancer Institute (NCI)RecruitingRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Ureter Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Recurrent Urethral Cancer | Stage III Urethral Cancer | Stage IV Urethral CancerUnited States
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Jerome Canady, M.D.Active, not recruitingStage IV Lung Cancer | Stage IV Bladder Cancer | Stage IV Pancreatic Cancer | Recurrent Malignant Solid Neoplasm | Stage IV Breast Cancer | Stage IV Renal Cell Cancer | Stage IV Prostate Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer | Stage IV Gastric Cancer | Stage IV Non-small Cell Lung Cancer | Stage... and other conditionsUnited States
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