Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Recruitment status was 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 mixed gliomas.
| 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 Mixed Glioma |
- 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: | March 1996 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy.
- Assess the response, 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 in the absence of toxicity and disease progression.
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, then annually thereafter.
PROJECTED ACCRUAL: This study will accrue 20-40 patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed incurable primary mixed glioma that is progressive, persistent, or recurrent following initial standard therapy, including radiation therapy
- Measurable disease by CT scan or MRI
- Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/mL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- No renal insufficiency
- Creatinine no greater than 2.5 mg/mL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No known chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No severe lung disease
- No severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No other severe medical illness
- No nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression)
Surgery:
- Fully recovered from prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | Recruiting |
| Houston, Texas, United States, 77055-6330 | |
| Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 info@burzynskiclinic.com | |
| 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: | NCT00003473 History of Changes |
| Other Study ID Numbers: | CDR0000066510, BC-BT-18 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult mixed glioma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013