Houston, Texas 77055


Purpose:

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with residual or recurrent anaplastic astrocytoma.


Study summary:

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.


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


NCT ID:

NCT00003537


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States

Stanislaw R. Burzynski, MD, PhD
Phone: 713-335-5697
Email: info@burzynskiclinic.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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