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Antineoplaston Therapy in Treating Patients With Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma

Sponsor
Burzynski Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00003500
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
51.2
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Current therapies for Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.

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

Detailed Description

Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma, 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 Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma.

  • 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 :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, Intermediate Grade
Actual Study Start Date :
Mar 11, 1996
Actual Primary Completion Date :
Jun 16, 2000
Actual Study Completion Date :
Jun 16, 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 Refractory or Recurrent Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma 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 proven stage II, III, or IV intermediate-grade non-Hodgkin's lymphoma that has not responded to or has relapsed after a standard primary chemotherapy regimen plus at least 1 standard second-line salvage chemotherapy regimen NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
      PATIENT CHARACTERISTICS:
      Age:
      • 18 and over
      Performance status:
      • Karnofsky 60-100%
      Life expectancy:
      • At least 2 months
      Hematopoietic:

      • WBC greater than 2000/mm^3

      • Platelet count greater than 50,000/mm^3

      Hepatic:
      • Bilirubin no greater than 2.5 mg/dL
      Renal:

      • 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 cardiovascular conditions that contraindicate high dosages of sodium

      Other:

      • Not pregnant or nursing

      • Fertile patients must use effective contraception during and for 4 weeks after study participation

      • No serious infection requiring treatment

      PRIOR CONCURRENT THERAPY:
      Biologic therapy:

      • At least 4 weeks since prior immunotherapy and recovered

      • No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)

      Chemotherapy:

      • See Disease Characteristics

      • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

      • No concurrent antineoplastic agents

      Endocrine therapy:

      • At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids

      • No concurrent corticosteroids

      Radiotherapy:
      • At least 8 weeks since prior radiotherapy and recovered
      Surgery:
      • Not specified
      Other:

      • Prior cytodifferentiation therapy allowed

      • No prior antineoplaston therapy

      • No concurrent antibiotics, antifungals, or antivirals

      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

      Publications

      None provided.
      Responsible Party:
      Burzynski Research Institute
      ClinicalTrials.gov Identifier:
      NCT00003500
      Other Study ID Numbers:
      • CDR0000066540
      • BC-LY-07
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Feb 5, 2018
      Last Verified:
      Feb 1, 2018
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Burzynski Research Institute
      Refractory Non-Hodgkin's Lymphoma
      Recurrent Non-Hodgkin's Lymphoma
      Intermediate-Grade Stage II - IV Non-Hodgkin's Lymphoma
      Additional relevant MeSH terms:
      Lymphoma
      Lymphoma, Non-Hodgkin

      Study Results

      No Results Posted as of Feb 5, 2018