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Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

Sponsor
Burzynski Research Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00003502
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 stage II, stage III, or stage IV mantle cell 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:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.

  • Evaluate the 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 antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for the third and fourth years, and then annually thereafter.

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 Stage II, III, or IV Mantle Cell 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 proven stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy

    • Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)

    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 20,000/mm^3

    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:

    • Creatinine no greater than 2.5 mg/dL

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

    Cardiovascular:

    • No 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 active infections 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:

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

    • No concurrent antineoplastic agent

    Endocrine therapy:

    • At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)

    • No concurrent dexamethasone, prednisone, or other corticosteroids

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

    • 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

    • 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:
    NCT00003502
    Other Study ID Numbers:
    • BC-LY-9
    • CDR0000066542
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Dec 1, 2006
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell

    Study Results

    No Results Posted as of Jul 10, 2013