Clinical Trial: Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma

This study is currently recruiting patients.

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)

Purpose

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 non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and bone marrow transplantation.

Condition Treatment or Intervention Phase
adult non-Hodgkin's lymphoma
 Drug: antineoplaston A10
 Drug: antineoplaston AS2-1
 Procedure: alternative product therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Who Have Failed High-Dose Chemotherapy and Bone Marrow Transplantation

Further Study Details: 

OBJECTIVES:

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 8 weeks 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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 20,000/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 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 4 weeks after study participation
  • No serious active infections

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

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids
  • No concurrent corticosteroids

Radiotherapy:

Surgery:

  • Not specified

Other:


Location and Contact Information


Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting
Stanislaw R. Burzynski, MD, PhD  713-335-5697    info@burzynskiclinic.com 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066537; BC-LY-3; NCT00003498
Record last reviewed:  August 2004
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003498
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005