Phase 2
N=40
Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
Glioblastoma Multiforme of the Brain
Bottom Line
View on ClinicalTrials.gov: NCT00003474 ↗Enrolled (actual)
40
Serious AEs
42.5%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Objective Response — 1; 1; 5; 19 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
- Jun 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
1; 1; 5; 19 | — |
| SECONDARY Percentage of Participants Who Survived |
45.0; 22.5; 2.5; 2.5; 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 residual/recurrent/progressive Glioblastoma Multiforme.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- 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
Data sourced from ClinicalTrials.gov (NCT00003474). 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.