Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other BC-MW-2 NCT00003512

Objectives

1. Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory Waldenstrom's macroglobulinemia.
2. Describe response, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Burzynski Clinic

Stanislaw Burzynski, MD, PhD, Protocol chair		Ph: 713-335-5697

Registry Information
Official Title		Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom
Trial Start Date		1998-08-06
Registered in ClinicalTrials.gov		NCT00003512
Date Submitted to PDQ		1998-08-06
Information Last Verified		2004-04-08

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