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


OBJECTIVES:

- Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with
incurable glioblastoma multiforme.

- Describe response, 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 six times a day until the maximum tolerated dose is reached. Patients
achieving complete response (CR) continue treatment for an additional 8 months after
reaching CR. Treatment continues for at least 3 months in the absence of unacceptable
toxicity or disease progression.

Tumors are measured every 2 months during the first year and every 3 months during the
second year.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed incurable glioblastoma multiforme that has progressed,
recurred, or persisted following completion of initial standard therapy (including
radiotherapy and/or chemotherapy)

- Measurable disease by MRI or CT scan

- Brain stem tumor is excluded

- 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 2,000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No liver failure

- Bilirubin no greater than 2.5 mg/dL

- SGOT/SGPT no greater than 5 times upper limit

Renal:

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

- Creatinine no greater than 2.5 mg/dL

Cardiovascular:

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No serious lung disease (e.g., severe COPD)

Other:

- Not pregnant or nursing

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

- No active infection

- No other serious medical or psychiatric conditions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since immunotherapy

- No concurrent immunomodulating agents

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since chemotherapy (unless radiologically proven progression)

- At least 6 weeks since nitrosoureas

Endocrine therapy:

- Corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 8 weeks since radiotherapy (unless radiologically proven progression)

Surgery:

- Recovered from prior surgery

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agent allowed

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:

CDR0000066511

NCT ID:

NCT00003474

Start Date:

August 1998

Completion Date:

Related Keywords:

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

Name

Location

Burzynski Research InstituteHouston, Texas  77055-6330