Phase 2
N=40
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Malignant Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00003475 ↗Enrolled (actual)
40
Serious AEs
52.5%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants With Objective Response — 2; 2; 4; 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
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
2; 2; 4; 19 | — |
| SECONDARY Percentage of Participants Who Survived |
47.5; 27.5; 2.5; 2.5; 2.5; 2.5 | — |
Summary
RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy 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 primary malignant brain tumors that have not responded to standard therapy.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed incurable adult primary malignant brain tumor
- Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
- Must have received and failed standard therapy
- Tumor must be at least 5 mm
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- Hematological function normal
- WBC at least 2000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- No liver failure
- No evidence of hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
Renal:
- No evidence of renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No chronic heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious lung disease, such as severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No medical or psychiatric illness that would preclude study treatment
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy
- At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy
- No concurrent antineoplastic agents
Endocrine therapy:
- Corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy
Surgery:
- At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy
Other:
- Recovered from prior therapy
- Cytodifferentiating agents allowed
Data sourced from ClinicalTrials.gov (NCT00003475). 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.