Phase 2
Completed N=27
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Anaplastic Astrocytoma
Source: ClinicalTrials.gov NCT00003470 ↗
Enrolled (actual)
27
Serious AEs
44.4%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Objective Response — 2; 3; 6; 10 Participants
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.
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 | — |
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. Informational only — not medical advice.