Phase 2
N=34
Antineoplaston Therapy in Treating Children With Brain Tumors
Childhood Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00003458 ↗Enrolled (actual)
34
Serious AEs
61.8%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Objective Response — 1; 5; 6; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antineoplaston therapy (Atengenal + Astugenal) (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Burzynski Research Institute
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
1; 5; 6; 18 | — |
| SECONDARY Percentage of Participants Who Survived |
64.7; 47.1; 35.3; 32.4; 20.6; 20.6 | — |
Summary
RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with brain tumors.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed (except if medically contraindicated) childhood brain tumor for which no curative therapy exists
- Measurable tumor by MRI scan performed within two weeks prior to study entry
- Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
- 6 months to 17 years
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC greater than 2000/mm^3
- Platelet count greater than 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
- 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 history of heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
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) and recovered
- 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)
Radiation therapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from any prior surgery
Other:
- No prior antineoplaston therapy
Data sourced from ClinicalTrials.gov (NCT00003458). 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.