Phase 2
N=40
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
Glioblastoma Multiforme of Brain
Bottom Line
View on ClinicalTrials.gov: NCT00003456 ↗Enrolled (actual)
40
Serious AEs
45.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Objective Response — 2; 1; 2; 27 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
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
2; 1; 2; 27 | — |
| SECONDARY Percentage of Participants Who Survived |
27.5; 12.5; 7.5; 5.0; 2.5; 2.5 | — |
Summary
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 newly diagnosed Glioblastoma Multiforme.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed Glioblastoma Multiforme
- Subtotal resection or biopsy only of tumor
- Measurable tumor by MRI scan performed within two weeks prior to study entry
- Tumor must be at least 5 mm
- No brain stem tumor
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 4 months
Hematopoietic:
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- No hepatic failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that would contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No concurrent immunomodulatory agents
Chemotherapy:
- No prior chemotherapy
- No concurrent antineoplastic agents
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
Data sourced from ClinicalTrials.gov (NCT00003456). 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.