Phase 2
N=40
Antineoplaston Therapy in Treating Patients With Brain Tumors
Refractory Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00003457 ↗Enrolled (actual)
40
Serious AEs
67.5%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants With Objective Response — 4; 5; 12; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antineoplaston therapy (Atengenal + Astugenal) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Burzynski Research Institute
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
4; 5; 12; 10 | — |
| SECONDARY Percentage of Participants Who Survived |
70.0; 50.0; 40.0; 35.0; 30.0; 22.5 | — |
Summary
RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with persistent or recurrent brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
- Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
- Tumor must be at least 5 mm
- Ineligible for other Burzynski Research Institute, Inc. brain tumor protocols
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- Hemoglobin at least 9 g/dL
- 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 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
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 concurrent 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 a stable dose for at least 1 week prior to study entry)
Radiotherapy:
- At least 8 weeks since prior radiotherapy
Surgery:
- Must recover from prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
Data sourced from ClinicalTrials.gov (NCT00003457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.