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

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 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

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