- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003487
Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus
Current therapies for Adenocarcinoma of the Esophagus provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Adenocarcinoma of the Esophagus.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Adenocarcinoma of the Esophagus.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Esophageal 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 esophageal 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 Esophageal Cancer.
- To determine objective response, tumor size is measured utilizing physical examination, and radiologic studies 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 confirmed adenocarcinoma of the esophagus that is unlikely to respond to existing therapy and for which no curative therapy exists
Meets 1 of the following criteria:
- Metastatic disease
- Not curable with surgery or radiotherapy
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- No hepatic failure
- 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/ml
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No chronic or congestive heart failure
- No uncontrolled hypertension
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious lung disease, such as severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No medical illness, psychiatric illness, or non-malignant systemic disease that would preclude study treatment
- 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 (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Concurrent steroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (except in patients with multiple tumors who have received radiotherapy to some of their tumors) and recovered
Surgery:
- Recovered from prior surgery
Other:
- No prior antineoplaston therapy
- Prior cytodifferentiating agents 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 Adenocarcinoma of the Esophagus 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Time Frame: 59 months
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Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks.
Stable Disease (SD), < 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
|
59 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stanislaw R Burzynski, MD, PhD, Burzynski Research Institute
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066525
- BC-ES-2 (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 Adenocarcinoma of the Esophagus
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Jules Bordet InstituteInnate PharmaWithdrawnAdenocarcinoma of the Gastroesophageal Junction | Squamous Cell Carcinoma of the Esophagus | Adenocarcinoma of the EsophagusBelgium
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Accelerated Community Oncology Research NetworkAmgenTerminatedGastroesophageal Adenocarcinoma | Adenocarcinomas of the Gastroesophageal Junction | Adenocarcinoma of the Distal Esophagus | Adenocarcinoma of the Proximal StomachUnited States
-
Translational Oncology Research InternationalSanofi; University of California, Los Angeles; OSI PharmaceuticalsCompletedUnresectable Adenocarcinoma of the Esophagus | Metastatic Adenocarcinoma of the Esophagus | Unresectable Adenocarcinoma of Gastric Cardia | Metastatic Adenocarcinoma of Gastric CardiaUnited States
-
Case Comprehensive Cancer CenterTerminatedAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma of the EsophagusUnited States
-
University of BolognaCompletedAdenocarcinoma of the Esophagus | Adenocarcinoma of the Gastric CardiaItaly
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage II Gastric Cancer | Stage III Gastric Cancer | Squamous Cell Carcinoma of the Esophagus | Adenocarcinoma of the Stomach | Adenocarcinoma of the Esophagus | Stage III Esophageal Cancer | Stage II Esophageal CancerUnited States
-
Erasmus Medical CenterNot yet recruitingEsophageal Cancer | Adenocarcinoma of the Esophagus
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Lund University HospitalCompletedAdenocarcinoma of the Esophagus or Esophagogastric JunctionSweden
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University of Colorado, DenverNational Cancer Institute (NCI)RecruitingAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma EsophagusUnited States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Squamous Cell Carcinoma of the Esophagus | Adenocarcinoma of the Esophagus | Recurrent Esophageal Cancer | Stage IV Esophageal Cancer | Stage III Esophageal CancerUnited States
Clinical Trials on Antineoplaston therapy (Atengenal + Astugenal)
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Burzynski Research InstituteCompletedLow Grade AstrocytomasUnited States
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Burzynski Research InstituteTerminatedMalignant MesotheliomaUnited States
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Burzynski Research InstituteTerminatedStage IV Non-small Cell Lung CancerUnited States
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Burzynski Research InstituteTerminatedStage IV Ovarian Cancer | Stage III Ovarian CancerUnited States
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Burzynski Research InstituteTerminatedSmall Intestine CancerUnited States
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Burzynski Research InstituteTerminatedNeuroblastomaUnited States
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Burzynski Research InstituteCompletedMalignant Brain TumorsUnited States
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Burzynski Research InstituteTerminated
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Burzynski Research InstituteTerminatedUnknown Primary CarcinomaUnited States
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Burzynski Research InstituteTerminatedMetastatic Prostate CancerUnited States