Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

Metastatic, Recurrent, or Refractory Neuroblastoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Neuroblastoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplas...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• * Histologically confirmed incurable neuroblastoma that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
• • Metastatic disease
• • Progressive, recurrent, or persistent disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy
• • Measurable disease by MRI or CT scan
• • Tumor must be at least 2 cm
• PATIENT CHARACTERISTICS:
• Age:
• • 6 months and over
• Performance status:
• • Karnofsky 60-100%
• Life expectancy:
• • At least 2 months
• Hematopoietic:
• • WBC at least 2,000/mm\^3
• • Platelet count at least 50,000/mm\^3
• Hepatic:
• • No hepatic insufficiency
• • Bilirubin no greater than 2.5 mg/dL
• • SGOT and SGPT no greater than 5 times upper limit of normal
• Renal:
• • No renal insufficiency
• • 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 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 nonmalignant systemic disease
• • Not a high medical or psychiatric risk
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • At least 4 weeks since prior immunotherapy
• • No concurrent immunomodulating agents
• Chemotherapy:
• • See Disease Characteristics
• • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• Endocrine therapy:
• • Concurrent corticosteroids allowed
• Radiotherapy:
• • See Disease Characteristics
• • At least 8 weeks since prior radiotherapy
• Surgery:
• • See Disease Characteristics
• • Recovered from prior surgery
• Other:
• • Prior cytodifferentiating agents allowed
• • No prior antineoplastons
• • No other concurrent antineoplastic agents