Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT00003474 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Results First Posted
: December 13, 2017
Last Update Posted
: March 22, 2018
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RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.
Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Multiforme of the Brain | Drug: Antineoplaston therapy (Atengenal + Astugenal) | Phase 2 |
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.
- 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.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme |
Actual Study Start Date : | March 14, 1996 |
Actual Primary Completion Date : | June 21, 2003 |
Actual Study Completion Date : | June 21, 2003 |
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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Drug: Antineoplaston therapy (Atengenal + Astugenal)
Adults with a residual/recurrent/progressive Glioblastoma Multiforme 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 Name: A10 (Atengenal); AS2-1 (Astugenal)
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- Number of Participants With Objective Response [ Time Frame: 12 months ]Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks.
- Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)
- Measurable disease by MRI or CT scan
- Brain stem tumor is excluded
- Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- No liver failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit
Renal:
- No history of renal conditions that contraindicate high dosages of sodium
- Creatinine no greater than 2.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious lung disease (e.g., severe COPD)
Other:
- Not pregnant or nursing
- Fertile patients must use adequate contraception during and for 4 weeks after study
- No active infection
- No other serious medical or psychiatric conditions
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since chemotherapy (unless radiologically proven progression)
- At least 6 weeks since nitrosoureas
Endocrine therapy:
- Corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since radiotherapy (unless radiologically proven progression)
Surgery:
- Recovered from prior surgery
Other:
- No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003474
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Principal Investigator: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Additional Information:
Responsible Party: | Burzynski Research Institute |
ClinicalTrials.gov Identifier: | NCT00003474 History of Changes |
Other Study ID Numbers: |
CDR0000066511 BRI-BT-20 ( Other Identifier: Burzynski Research Institute ) |
First Posted: | January 27, 2003 Key Record Dates |
Results First Posted: | December 13, 2017 |
Last Update Posted: | March 22, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Keywords provided by Burzynski Research Institute:
adult glioblastoma recurrent glioblastoma |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |