Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
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ClinicalTrials.gov Identifier: NCT00003512 |
Recruitment Status :
Withdrawn
(No participants enrolled)
First Posted : January 27, 2003
Last Update Posted : February 5, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
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Waldenstrom Macroglobulinemia | Drug: Antineoplaston therapy (Atengenal + Astugenal) | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom |
Actual Study Start Date : | February 18, 1999 |
Actual Primary Completion Date : | April 26, 2000 |
Actual Study Completion Date : | April 26, 2000 |

Arm | Intervention/treatment |
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Experimental: Antineoplaston therapy
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.
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Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1. Other Name: A10 (Atengenal); AS2-1 (Astugenal) |

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003512
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Principal Investigator: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Responsible Party: | Burzynski Research Institute |
ClinicalTrials.gov Identifier: | NCT00003512 |
Other Study ID Numbers: |
CDR0000066555 BC-MW-2 ( Other Identifier: Burzynski Research Institute ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 5, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Waldenstrom Macroglobulinemia Recurrent Waldenstrom Macroglobulinemia Refractory |
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |