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


Phase 2
N/A
N/A
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

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


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with metastatic, recurrent, or refractory neuroblastoma.

- Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times a day until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066556

NCT ID:

NCT00003513

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Neuroblastoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • stage 4S neuroblastoma
  • recurrent neuroblastoma
  • localized unresectable neuroblastoma
  • Neuroblastoma

Name

Location

Burzynski ClinicHouston, Texas  77055-6330