- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003496
Antineoplaston Therapy in Treating Patients With Recurrent or Extensive-Stage Small Cell Lung Cancer
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Small Cell Carcinoma of the Lung
Current therapies for Recurrent or Extensive-Stage Small Cell Lung 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 Recurrent or Extensive-Stage Small Cell Lung Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Extensive-Stage Small Cell Lung Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OVERVIEW: This is a single arm, open-label study in which patients with Recurrent or Extensive-Stage Small Cell Lung Cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Extensive-Stage Small Cell Lung 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 Recurrent or Extensive-Stage Small Cell Lung 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 confirmed recurrent or extensive stage small cell lung cancer unlikely to have a curative response to existing standard regimens
Measurable disease by MRI or CT scan
- At least 2 cm in diameter
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- 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
Pulmonary:
- No severe lung disease (e.g., chronic obstructive pulmonary disease)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No active infections
- No other concurrent serious disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agents
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from prior surgery
Other:
- No prior antineoplaston therapy
- 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 Recurrent or Extensive-Stage Small Cell Lung 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
- CDR0000066535
- BC-LA-07 (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 Small Cell Lung Cancer Extensive Stage
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Zhejiang Cancer HospitalRecruitingExtensive Stage Lung Small Cell CancerChina
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
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National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
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European Organisation for Research and Treatment...UNICANCERRecruitingExtensive-stage Small-cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited Kingdom, Belgium, Switzerland, Italy, France, Germany, Poland, Spain, Austria
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Intergroupe Francophone de Cancerologie ThoraciqueCompletedSmall Cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive StageFrance
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell CarcinomaUnited States
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University of WashingtonAstraZenecaWithdrawnStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell CarcinomaUnited States
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National Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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National Cancer Institute (NCI)CompletedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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