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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
This study is ongoing, but not recruiting participants.
Study NCT00003512   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: November 16, 2008   History of Changes

November 1, 1999
November 16, 2008
August 1998
 
 
 
Complete list of historical versions of study NCT00003512 on ClinicalTrials.gov Archive Site
 
 
 
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom

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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory Waldenstrom's macroglobulinemia.

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory Waldenstrom's macroglobulinemia.
  • Describe 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 antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months the first year and every 3 months the second year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • 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
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy

    • Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
    • Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination)
  • Biochemical evidence of Waldenstrom's macroglobulinemia

    • Abnormal proteins in serum and urine

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2000/mm3
  • Platelet count at least 50,000/mm3

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:

  • No renal insufficiency
  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

  • No serious lung disease, such as chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No active infection
  • No non-malignant systemic disease
  • Not a high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent immunomodulating agent

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy
  • No concurrent antineoplastic agents

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • No prior antineoplastons
  • Prior cytodifferentiating agents allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003512
 
CDR0000066555, BC-MW-2
Burzynski Research Institute
 
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
April 2004

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