Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: November 16, 2008
Last verified: April 2004

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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory Waldenstrom's macroglobulinemia.

Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:


  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory Waldenstrom's macroglobulinemia.
  • Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months the first year and every 3 months the second year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months


  • WBC at least 2000/mm3
  • Platelet count at least 50,000/mm3


  • No hepatic insufficiency
  • Bilirubin no greater than 2.5 mg/dL
  • SGOT and SGPT no greater than 5 times upper limit of normal


  • No renal insufficiency
  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium


  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium


  • No serious lung disease, such as chronic obstructive pulmonary disease


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent immunomodulating agent


  • 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


  • See Disease Characteristics
  • At least 8 weeks since prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • No prior antineoplastons
  • Prior cytodifferentiating agents allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003512

United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
No publications provided Identifier: NCT00003512     History of Changes
Other Study ID Numbers: CDR0000066555, BC-MW-2
Study First Received: November 1, 1999
Last Updated: November 16, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
Waldenstrom macroglobulinemia

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases processed this record on October 02, 2015