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

Sponsor
Burzynski Research Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00003512
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
14.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antineoplaston therapy (Atengenal + Astugenal)
 Phase 2

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 Design

Study Type:
Interventional
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 :
Feb 18, 1999
Actual Primary Completion Date :
Apr 26, 2000
Actual Study Completion Date :
Apr 26, 2000

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • A10 (Atengenal); AS2-1 (Astugenal)

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 99 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Burzynski Clinic Houston Texas United States 77055-6330

      Sponsors and Collaborators

      • Burzynski Research Institute

      Investigators

      • Principal Investigator: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Burzynski Research Institute
      ClinicalTrials.gov Identifier:
      NCT00003512
      Other Study ID Numbers:
      • CDR0000066555
      • BC-MW-2
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Feb 5, 2018
      Last Verified:
      Feb 1, 2018
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Burzynski Research Institute
      Waldenstrom Macroglobulinemia Recurrent
      Waldenstrom Macroglobulinemia Refractory
      Additional relevant MeSH terms:
      Waldenstrom Macroglobulinemia

      Study Results

      No Results Posted as of Feb 5, 2018