Clinical trial
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Low Grade Astrocytoma
Name
CDR0000066504
Description
RATIONALE: Current therapies for children with low grade astrocytomas that have not responded to standard therapy provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with low grade 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 children (\> 6 months of age) with low grade astrocytomas that has not responded to standard therapy.
Trial arms
Trial start
1996-07-01
Estimated PCD
2004-07-01
Trial end
2004-07-01
Status
Completed
Phase
Early phase I
Treatment
Antineoplaston therapy (Atengenal + Astugenal)
Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Arms:
Antineoplaston therapy
Other names:
A10 (Atengenal); AS2-1 (Astugenal)
Size
11
Primary endpoint
Number of Participants With Objective Response
12 months
Eligibility criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed low grade astrocytoma.
* Evidence of persistent or progressive tumor after standard therapy by MRI scan performed within 2 weeks prior to study entry
* Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
* 6 months to 17 years
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count greater than 50,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/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 severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No severe lung disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections or fever
* 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 for cerebral edema allowed (must be on stable dose for at least 1 week prior to study entry)
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No prior antineoplaston therapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2023-11-21
1 organization
1 product
1 indication
Organization
Burzynski Research InstituteProduct
Antineoplaston therapyIndication
Low Grade Astrocytoma