Biologically based therapies |
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Clinical Trial: Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
This study is no longer recruiting patients.
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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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult glioblastoma | Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Procedure: alternative product therapy Procedure: biological response modifier therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: 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
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
Texas
Burzynski Clinic, Houston, Texas, 77055-6330, United States
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003456
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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