Brief Title
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom
Brief Summary
Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's Macroglobulinemia. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia.
Detailed Description
Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: - To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia, as measured by an objective response to therapy (complete response, partial response or stable disease). - To determine the safety and tolerance of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia. - To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
Study Phase
Phase 2
Study Type
Interventional
Condition
Waldenstrom Macroglobulinemia
Intervention
Antineoplaston therapy (Atengenal + Astugenal)
Study Arms / Comparison Groups
Antineoplaston therapy
Description: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
February 18, 1999
Completion Date
April 26, 2000
Primary Completion Date
April 26, 2000
Eligibility Criteria
DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan - Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination) - Biochemical evidence of Waldenstrom's macroglobulinemia - Abnormal proteins in serum and urine PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm3 - Platelet count at least 50,000/mm3 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: - No renal insufficiency - 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 other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study - No active infection - No non-malignant systemic disease - Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulating agent Chemotherapy: - See Disease Characteristics - At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy - No concurrent antineoplastic agents Endocrine therapy: - See Disease Characteristics - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - No prior antineoplastons - Prior cytodifferentiating agents allowed
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Stanislaw R. Burzynski, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003512
Organization ID
CDR0000066555
Secondary IDs
BC-MW-2
Responsible Party
Sponsor
Study Sponsor
Burzynski Research Institute
Study Sponsor
Stanislaw R. Burzynski, MD, PhD, Principal Investigator, Burzynski Research Institute
Verification Date
February 2018