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Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma


Phase 2
18 Years
N/A
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 Adult Patients With Mixed Glioma


OBJECTIVES:

- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients
with incurable progressive, recurrent, or persistent mixed gliomas following standard
therapy.

- Assess the 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 daily until the maximum tolerated dose is reached.
Treatment continues in the absence of toxicity and disease progression.

Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4
months for the third and fourth years, every 4-6 months for the fifth year, then annually
thereafter.

PROJECTED ACCRUAL: This study will accrue 20-40 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed incurable primary mixed glioma that is progressive,
persistent, or recurrent following initial standard therapy, including radiation
therapy

- Measurable disease by CT scan or MRI

- Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/mL

- SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/mL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No known chronic heart failure

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe lung disease

- No severe chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study

- No other severe medical illness

- No nonmalignant systemic disease

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since immunotherapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (unless there is evidence of disease
progression)

Surgery:

- Fully recovered from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements taken at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

Unspecified

Study ID:

CDR0000066510

NCT ID:

NCT00003473

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330