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Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Sponsor
Burzynski Research Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00003505
Collaborator
(none)
0
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 is studying how well antineoplaston therapy works in treating patients with primary central nervous system lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
  • Procedure: alternative product therapy
  • Procedure: biological therapy
  • Procedure: biologically based therapies
  • Procedure: cancer prevention intervention
  • Procedure: complementary and alternative therapy
  • Procedure: differentiation therapy
 Phase 2

Detailed Description

OBJECTIVES:

  • Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system lymphoma.

  • Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists

    • Measurable tumor by MRI or CT scan

    • Tumor must be greater than 2 cm in largest diameter

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 60-100%
    Life expectancy:
    • At least 2 months
    Hematopoietic:

    • WBC greater than 2,000/mm^3

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

    Hepatic:

    • Bilirubin no greater than 2.5 mg/dL

    • SGOT and SGPT no greater than 5 times upper limit of normal

    • No hepatic insufficiency

    Renal:

    • Creatinine no greater than 2.5 mg/dL

    • No history of renal conditions that contraindicate high dosages of sodium

    Cardiovascular:

    • No cardiac insufficiency

    • No hypertension

    • No history of congestive heart failure

    • No history of other cardiovascular conditions that contraindicate high dosages of sodium

    Other:

    • Not pregnant or nursing

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

    • No serious infection requiring antibiotics, antifungals, or antivirals

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • At least 4 weeks since prior immunotherapy and recovered

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

    Chemotherapy:

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

    • No concurrent antineoplastic agent

    Endocrine therapy:

    • Concurrent corticosteroids allowed

    • Must be on stable dose for at least 4 weeks prior to study entry

    Radiotherapy:
    • At least 8 weeks since prior radiotherapy and recovered
    Surgery:
    • Not specified
    Other:
    • No prior antineoplastons

    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

    • Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003505
    Other Study ID Numbers:
    • BC-LY-12
    • CDR0000066545
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Oct 1, 2006
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Jul 10, 2013