Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
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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 advanced mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma |
- 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:
- Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV mesothelioma.
- Describe the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV six times per day until the maximum dose is reached.
Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for at least 8 months beyond CR.
Patients are followed every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists
- Evidence of disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 1 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 and SGPT no greater than 5 times upper limit of normal
- Hepatic function adequate
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious 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
- Not at high medical or psychiatric risk
- No nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents
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
No publications provided
| Responsible Party: | Stanislaw R. Burzynski, Burzynski Clinic |
| ClinicalTrials.gov Identifier: | NCT00003508 History of Changes |
| Other Study ID Numbers: | CDR0000066551, BC-MA-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 31, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
advanced malignant mesothelioma recurrent malignant mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
ClinicalTrials.gov processed this record on June 13, 2013