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Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma


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 Anaplastic Astrocytoma


OBJECTIVES:

- Determine the objective response rate in patients with anaplastic astrocytoma treated
with antineoplastons A10 and AS2-1 after subtotal resection.

- Assess 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
IV 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 stable disease or partial response may continue treatment. Patients achieving
complete response (CR) continue treatment for an additional 8 months after CR.

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

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed anaplastic astrocytoma

- 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 tumors

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 2 months

Hematopoietic:

- WBC at least 1,500/mm^3

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

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT and 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

Cardiovascular:

- No prior congestive heart failure

- No coronary artery disease

- No myocardial infarction within the past year

- No angina requiring medication

- No uncontrolled hypertension

Pulmonary:

- No moderate to severe chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

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

- No active infection

- No other concurrent serious disease

- No other prior malignancy except carcinoma in situ of the cervix or superficial
nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

- No concurrent immunomodulating agents

Chemotherapy:

- No prior myelosuppressive chemotherapy

Endocrine therapy:

- Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

- No prior myelosuppressive radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from any prior surgery

Other:

- No prior cytodifferentiating agents

- No prior antineoplaston therapy

- No other concurrent antineoplastic agents

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:

Unspecified

Study ID:

CDR0000066585

NCT ID:

NCT00003537

Start Date:

April 1995

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330