Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.
* Evaluate 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 antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.

Tumors are measure...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically proven stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy
• • Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)
• 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 20,000/mm\^3
• Hepatic:
• • No hepatic insufficiency
• • Bilirubin no greater than 2.5 mg/dL
• • SGOT and SGPT no greater than 5 times upper limit of normal
• Renal:
• • Creatinine no greater than 2.5 mg/dL
• • No history of renal conditions that contraindicate high dosages of sodium
• Cardiovascular:
• • No 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 active infections 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:
• • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• • No concurrent antineoplastic agent
• Endocrine therapy:
• • At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)
• • No concurrent dexamethasone, prednisone, or other corticosteroids
• Radiotherapy:
• • At least 8 weeks since prior radiotherapy and recovered
• Surgery:
• • Not specified
• Other:
• • No prior antineoplaston therapy
• • No concurrent antibiotics, antifungals, or antivirals