Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
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| ClinicalTrials.gov Identifier: NCT00003459 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : October 12, 2016
Last Update Posted : March 14, 2018
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RATIONALE: Current therapies for a brain stem glioma 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 stem gliomas.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Stem Gliomas | Drug: Antineoplaston therapy (Atengenal + Astugenal) | Phase 2 |
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma, 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 a brain stem glioma.
OVERVIEW: This is a single arm, open-label study in which patients 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. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.
To determine objective response, tumor size in measured utilizing MRI scans, which are performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years, every 6 months for the 5th and 6th years, and annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for 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 Patients With Brain Stem Glioma |
| Study Start Date : | March 1996 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | September 2007 |
| Arm | Intervention/treatment |
|---|---|
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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 dosage is reached.
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Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)
Other Name: A10 (Atengenal); AS2-1 (Astugenal) |
- 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: | 6 Months to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed (except if medically contraindicated) brain stem glioma that is unlikely to respond to existing therapy and for which no curative therapy exists.
- Tumor must be at least 5 mm in maximum diameter
PATIENT CHARACTERISTICS:
Age:
- 6 months or greater
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count greater than 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 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 other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No severe lung disease
Other:
- 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 concomitant disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No concurrent antineoplastic agents
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry)
Radiotherapy:
- At least 8 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No prior Antineoplaston therapy
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): NCT00003459
| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Principal Investigator: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Additional Information:
Publications:
| Responsible Party: | Burzynski Research Institute |
| ClinicalTrials.gov Identifier: | NCT00003459 History of Changes |
| Other Study ID Numbers: |
CDR0000066491 BC-BT-11 ( Other Identifier: Burzynski Research Institute, Inc ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | October 12, 2016 |
| Last Update Posted: | March 14, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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recurrent adult brain stem glioma untreated adult brain stem glioma untreated childhood brain stem glioma recurrent childhood brain stem glioma |
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Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |