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


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 Patients With Glioblastoma Multiforme


OBJECTIVES:

- Determine the objective response rate to escalating doses of antineoplastons A10 and
AS2-1 in patients with glioblastoma multiforme.

- Assess tolerance to and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times daily 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 CR.

Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed glioblastoma multiforme

- Tumor subtotally resected or biopsied

- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI,
CT scan, or positron-emission tomography

- No brain stem tumor

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 4 months

Hematopoietic:

- WBC at least 1,500/mm^3

- Platelet count at least 50,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- No hepatic failure

- Bilirubin no greater than 2.5 mg/dL

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

Renal:

- Creatinine no greater than 2.5 mg/dL

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

Cardiovascular:

- No uncontrolled hypertension

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

- No concurrent immunomodulatory agents

Chemotherapy:

- No prior chemotherapy

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from any prior surgery

Type of Study:

Interventional

Study Design:

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:

CDR0000066488

NCT ID:

NCT00003456

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330