Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma
Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Advanced Mesothelioma 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 advanced Mesothelioma, 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 advanced Mesothelioma.
- 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
-
-
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 stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists
- Evidence of disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 1 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 and SGPT no greater than 5 times upper limit of normal
- Hepatic function adequate
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 uncontrolled hypertension
- No history of congestive heart failure
- No cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious 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
- Not at high medical or psychiatric risk
- No nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents
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: Arm: 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.
|
Patients with advanced mesothelioma 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.hourly interEach 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: 109 months
|
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.
|
109 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute
Publications and helpful links
General Publications
- Preliminary findings on the use of targeted therapy in combination with sodium phenylbutyrate in advanced malignant mesothelioma: A strategy for improved survival. Journal of Cancer Therapy. 2014; 5:1127-1144.
- Burzynski SR, Lewy RI, Axler M, Janicki TJ.Treatment of malignant mesothelioma (MM) with sodium phenylbutyrate.Presented at the 15th International Congress on Anti-Cancer Treatment; February 9-12, 2004, Paris, France.
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
- CDR0000066551
- BC-MA-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
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