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Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors


Phase 2
N/A
17 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors


OBJECTIVES:

- Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with
primitive neuroectodermal tumors by determining the proportion of patients who
experience an objective tumor response.

- Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times a day until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of disease progression or unacceptable
toxicity. After 2 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed (except if medically contraindicated) incurable primitive
neuroectodermal tumor

- Evidence of progressive or recurrent tumor by MRI or CT 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate assessed by tumor measurements at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066492

NCT ID:

NCT00003460

Start Date:

September 1995

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

Burzynski ClinicHouston, Texas  77055-6330