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Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma


Phase 2
N/A
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 Infusions in Patients With Ependymoma


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
ependymoma by determining the proportion of patients who experience an objective tumor
response.

- Evaluate the adverse side effects and tolerance to 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 for at least 12 months in the absence of disease progression and
unacceptable toxicity. After 12 months, patients with stable disease may continue treatment.

Tumors are measured at least every 8 weeks during the first 2 years, every 3 months during
the third and fourth years, every 6 months during the fifth and sixth years, and yearly
thereafter.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ependymoma that is unlikely to respond to existing therapy
and for which no curative therapy exists

- Evidence of tumor by MRI or CT scan

- Tumor must be at least 5 mm

- No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

- 6 months and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm3

- Platelet count greater than 50,000/mm3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

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

- No hepatic failure

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal failure

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

Cardiovascular:

- No severe heart disease

- No uncontrolled hypertension

- No history of congestive heart failure

- No history of 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

- No serious active infections or fever

- No other serious concurrent 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 and recovered (6 weeks for nitrosoureas)

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at
least 1 week prior to study)

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No prior antineoplaston therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

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:

CDR0000066516

NCT ID:

NCT00003479

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult ependymoma
  • newly diagnosed childhood ependymoma
  • recurrent childhood ependymoma
  • adult anaplastic ependymoma
  • Ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330