Phase 2
N=19
Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Adult Brain Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00003537 ↗Enrolled (actual)
19
Serious AEs
57.9%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Objective Response — 3; 1; 5; 9 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
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
3; 1; 5; 9 | — |
| SECONDARY Percentage of Participants Who Survived |
68.4; 52.6; 36.8; 26.3; 26.3; 21.1 | — |
Summary
RATIONALE: Current therapies for adults with anaplastic astrocytoma provide 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 astrocytoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma
- Tumor subtotally resected or biopsied prior to therapy
- Evidence of residual tumor by MRI scan performed within two weeks prior to study entry
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
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 renal failure
Cardiovascular:
- No prior congestive heart failure
- No coronary artery disease
- No myocardial infarction within the past year
- No angina requiring medication
- No uncontrolled hypertension
Pulmonary:
- No moderate to 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 active infection
- No other concurrent serious disease
- No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- No prior myelosuppressive chemotherapy
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
- No prior myelosuppressive radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
Other:
- No prior cytodifferentiating agents
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
Data sourced from ClinicalTrials.gov (NCT00003537). 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.