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

Neuroblastoma Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Neuroblastoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003513
• Other study ID #: CDR0000066556
• Secondary ID: BC-NB-2
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 26, 2017
• Start date: December 16, 1996
• Est. completion date: March 29, 1999

Study information

• Verified date: September 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 29, 1999
• Est. primary completion date: March 29, 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients With Metastatic, Recurrent, or Refractory Neuroblastoma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute