Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003502
First received: November 1, 1999
Last updated: July 9, 2013
Last verified: December 2006

November 1, 1999
July 9, 2013
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003502 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Contiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003502
BC-LY-9, CDR0000066542
Not Provided
Not Provided
Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
December 2006

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