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Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00003499   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: August 12, 2009   History of Changes

November 1, 1999
August 12, 2009
March 1996
December 2011   (final data collection date for primary outcome measure)
Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]
Response rate based on tumor measurements taken at 12 weeks
Complete list of historical versions of study NCT00003499 on ClinicalTrials.gov Archive Site
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
Survival at 1, 2, and 5 years from the start of treatment
 
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Low Grade

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 low-grade non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening low grade non-Hodgkin's lymphoma.
  • Describe the response, 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 and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for the first 6 months, every 3 months for the first 2 years, every 6 months for years 3 and 4, and yearly for years 5 and 6.

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

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
 
December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists 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 2,000/mm^3
  • Platelet count greater than 20,000/mm^3

Hepatic:

  • Bilirubin normal

Renal:

  • Creatinine normal
  • 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
  • No serious active infections

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since immunotherapy and recovered
  • No concurrent immunomodulating agents (e.g., interferon, 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:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No prior antineoplaston therapy
  • No other concurrent antineoplastic agents
  • No concurrent antibiotics, antifungals, or antivirals
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003499
Stanislaw R. Burzynski, Burzynski Clinic
CDR0000066538, BC-LY-6
Burzynski Research Institute
 
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP