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

Burzynski Research Institute

Status and phase: Terminated; Phase 2

Conditions: Neuroblastoma

Treatments: Drug: Antineoplaston therapy (Atengenal + Astugenal)

Study type: Interventional

Funder types: Other

Identifiers

NCT00003513

BC-NB-2 (Other Identifier)

CDR0000066556

Details and patient eligibility

About

Current therapies for Metastatic, Recurrent, or Refractory Neuroblastoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Neuroblastoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Neuroblastoma.

Full description

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 Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Neuroblastoma.
• To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Enrollment: 3 patients

Sex: All

Ages: 6 months to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Antineoplaston therapy

Experimental group

Description:

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Treatment:

Drug: Antineoplaston therapy (Atengenal + Astugenal)