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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003500
Recruitment Status : Terminated (slow accrual)
First Posted : January 27, 2003
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

Study Description
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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
Non-hodgkins Lymphoma 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
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Study Type : Interventional  (Clinical Trial)
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 : March 11, 1996
Actual Primary Completion Date : June 16, 2000
Actual Study Completion Date : June 16, 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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 Name: A10 (Atengenal); AS2-1 (Astugenal)


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
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Information from the National Library of Medicine

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): NCT00003500


Locations
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United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
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Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
More Information
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Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003500    
Other Study ID Numbers: CDR0000066540
BC-LY-07 ( Other Identifier: Burzynski Research Institute )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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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:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases