Non-hodgkins Lymphoma Clinical Trial
Official title:
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, Intermediate Grade
Verified date | February 2018 |
Source | Burzynski Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current therapies for Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's
Lymphoma provide very limited benefit to the patient. The anti-cancer properties of
Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or
Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Refractory or Recurrent Intermediate-Grade Stage
II - IV Non-Hodgkin's Lymphoma.
Status | Terminated |
Enrollment | 12 |
Est. completion date | June 16, 2000 |
Est. primary completion date | June 16, 2000 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven stage II, III, or IV intermediate-grade non-Hodgkin's lymphoma that has not responded to or has relapsed after a standard primary chemotherapy regimen plus at least 1 standard second-line salvage chemotherapy regimen NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC greater than 2000/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No history of cardiovascular conditions that contraindicate high dosages of sodium Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious infection requiring treatment PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulatory agent (e.g., interferon or interleukin-2) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids - No concurrent corticosteroids Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - Prior cytodifferentiation therapy allowed - No prior antineoplaston therapy - No concurrent antibiotics, antifungals, or antivirals |
Country | Name | City | State |
---|---|---|---|
United States | Burzynski Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Burzynski Research Institute |
United States,
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