Therapy in Treating Patients With Advanced Mesothelioma
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) September 2003
| Sponsored by: |
Burzynski Research Institute |
| Information provided by: |
National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: |
NCT00003508 | |
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 |
advanced malignant mesothelioma
recurrent malignant mesothelioma
|
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 Therapies; Mesothelioma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Mesothelioma
Further Study Details:
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 above, Genders Eligible for Study: Both
Criteria
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:
Performance status:
Life expectancy:
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00003508
Texas Burzynski Clinic, Houston, Texas, 77055-6330, United States; Recruiting
Study chairs or principal investigators
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000066551; BC-MA-2
Last Updated: September 9, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier:
NCT00003508Health Authority: United States: Federal Government
