Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Recruitment status was Active, not recruiting
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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 is studying how well antineoplaston therapy works in treating patients with recurrent or refractory oligodendroglioma after previous chemotherapy, radiation therapy, and/or biological therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma |
- Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 1996 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory oligodendroglioma.
- Describe response to, 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 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy
- Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography
- Measurable disease by MRI or CT scan
- Tumor must be at least 5 mm
- Must have received and failed prior standard therapy (i.e., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent)
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No severe lung disease (e.g., chronic obstructive pulmonary disease)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No serious active infections
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy
Surgery:
- Recovered from any prior surgery
Other:
- No prior antineoplaston therapy
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stanislaw R. Burzynski, Burzynski Clinic |
| ClinicalTrials.gov Identifier: | NCT00003472 History of Changes |
| Other Study ID Numbers: | CDR0000066509, BC-BT-17 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 14, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult anaplastic oligodendroglioma adult oligodendroglioma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Oligodendroglioma Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Glioma |
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013