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

• ClinicalTrials.gov Identifier: NCT00003512
• Recruitment Status: Withdrawn
• First Posted: January 27, 2003
• Last Update Posted: February 5, 2018
• Sponsor: Burzynski Research Institute
• Information provided by (Responsible Party): Burzynski Research Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Waldenstrom Macroglobulinemia	Drug: Antineoplaston therapy (Atengenal + Astugenal)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom
• Actual Study Start Date: February 18, 1999
• Actual Primary Completion Date: April 26, 2000
• Actual Study Completion Date: April 26, 2000

Arms and Interventions

Arm

Intervention/treatment

Experimental: Antineoplaston therapy; Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

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.; Other Name: A10 (Atengenal); AS2-1 (Astugenal)

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

United States, Texas

Burzynski Clinic

Houston, Texas, United States, 77055-6330

Sponsors and Collaborators

Burzynski Research Institute

Investigators

• Principal Investigator: Stanislaw R. Burzynski, MD, PhD; Burzynski Research Institute

More Information

Additional Information:

Burzynski Research Institute 

Burzynski Clinic 

• Responsible Party: Burzynski Research Institute
• ClinicalTrials.gov Identifier: NCT00003512
• Other Study ID Numbers: CDR0000066555; BC-MW-2 ( Other Identifier: Burzynski Research Institute )
• First Posted: January 27, 2003
• Last Update Posted: February 5, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Burzynski Research Institute:

Waldenstrom Macroglobulinemia Recurrent; Waldenstrom Macroglobulinemia Refractory

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases