Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with primitive neuroectodermal tumors that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in children with a brain tumor.

OVERVIEW: This is a single arm, open-label study in which children with primitive neuroectodermal tumors that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed (except if medically contraindicated) incurable primitive neuroectodermal tumor
• • Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
• • Must have received and failed prior standard therapy
• • 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 2000/mm\^3
• • Platelet count greater than 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 insufficiency
• 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 severe heart disease
• • 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 concomitant 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 a 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 treatment