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

Waldenstrom Macroglobulinemia Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003512
• Other study ID #: CDR0000066555
• Secondary ID: BC-MW-2
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 1, 2018
• Start date: February 18, 1999
• Est. completion date: April 26, 2000

Study information

• Verified date: February 2018
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's Macroglobulinemia.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia.

Description:

Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia, as measured by an objective response to therapy (complete response, partial response or stable disease).

• To determine the safety and tolerance of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia.

• To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 26, 2000
• Est. primary completion date: April 26, 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute