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Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma



Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma

For Condition: recurrent adult brain tumor,adult anaplastic astrocytoma
Status: Recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: 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 studies the effectiveness of antineoplaston therapy in treating patients who have residual or recurrent anaplasticastrocytoma.
Details: 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 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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: - 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: - Prior immunotherapy allowed - 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: - Prior cytodifferentiating agents allowed - No prior antineoplaston therapy - No other concurrent antineoplastic agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanislawBurzynski,  Study Chair,  Burzynski Research Institute

Burzynski Clinic *Recruiting*
Houston,  Texas,  77055-6330
United States
Recruiting Stanislaw  Burzynski 713-335-5697


Additional Information:
Study ID Numbers:  CDR0000066585;  BC-BT-8
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003537

Other Recurrent Adult Brain Tumor Studies:
1. Imatinib Mesylate in Treating Patients With Recurrent Meningioma

2. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors

3. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma

4. Karenitecin in Treating Patients With Recurrent Malignant Glioma

5. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

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