Phase 2
N=20
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Mixed Gliomas
Bottom Line
View on ClinicalTrials.gov: NCT00003473 ↗Enrolled (actual)
20
Serious AEs
40.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Participants With Objective Response — 3; 0; 4; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atengenal (Drug); Astugenal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Burzynski Research Institute
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
3; 0; 4; 10 | — |
| SECONDARY Percentage of Participants Who Survived |
65.0; 55.0; 30.0; 30.0; 20.0; 15.0 | — |
Summary
RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas 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 recurrent or refractory mixed gliomas.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy
- Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry
- Must have received and failed standard therapy
- 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 2000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/mL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- No renal insufficiency
- Creatinine no greater than 2.5 mg/mL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No known chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No severe lung disease
- No severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No other severe medical illness
- No nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression)
Surgery:
- Fully recovered from prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
Data sourced from ClinicalTrials.gov (NCT00003473). 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.