Phase 2
N=27
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Anaplastic Astrocytoma
Bottom Line
View on ClinicalTrials.gov: NCT00003470 ↗Enrolled (actual)
27
Serious AEs
44.4%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants With Objective Response — 2; 3; 6; 10 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 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
2; 3; 6; 10 | — |
| SECONDARY Percentage of Participants Who Survived |
63.0; 40.7; 29.6; 22.2; 14.8; 11.1 | — |
Summary
RATIONALE: Current therapies for adults with anaplastic astrocytomas 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 anaplastic astrocytomas 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 anaplastic astrocytomas that have not responded to standard therapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed incurable adult anaplastic astrocytoma
- 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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm^3
- Platelet count at least 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 uncontrolled hypertension
- No history of congestive heart failure
- No history of 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
- No active infection
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- 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 allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Fully recovered from any prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
Data sourced from ClinicalTrials.gov (NCT00003470). 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.