Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma - Article
Clinical Trial: Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
This study is currently recruiting patients.
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 non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and bone marrow transplantation.
|Condition||Treatment or Intervention||Phase|
|adult non-Hodgkin's lymphoma || 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: Lymphoma
Study Type: Interventional
Study Design: Treatment
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation.
- Describe the 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 intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically proven non-Hodgkin's disease that has failed both prior high-dose chemotherapy and bone marrow transplantation
PATIENT CHARACTERISTICS: Age:
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC greater than 2,000/mm^3
- Platelet count greater than 20,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No serious active infections
PRIOR CONCURRENT THERAPY: Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents (e.g., interferon or interleukin-2)
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- At least 4 weeks since prior corticosteroids
- No concurrent corticosteroids
- At least 8 weeks since prior radiotherapy and recovered
- Not specified
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
- No concurrent antibiotics, antifungals, or antivirals
Location and Contact Information
Burzynski Clinic, Houston, Texas, 77055-6330, United States; Recruiting
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute
Record last reviewed: August 2004
Last Updated: February 7, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003498
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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