Antineoplaston Therapy in Treating Patients With Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT00003511
• Recruitment Status: Terminated
• First Posted: January 27, 2003
• Results First Posted: January 28, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Burzynski Research Institute
• Information provided by (Responsible Party): Burzynski Research Institute

Study Description

Brief Summary:

Current therapies for Multiple Myeloma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Multiple Myeloma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Multiple Myeloma.

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

Detailed Description:

Multiple Myeloma 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 Multiple Myeloma, 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 Multiple Myeloma.
• 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: 5 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 Multiple Myeloma
• Actual Study Start Date: April 4, 1996
• Actual Primary Completion Date: October 21, 1999
• Actual Study Completion Date: October 21, 1999

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 Multiple Myeloma 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

Primary Outcome Measures :

1. Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable [ Time Frame: 36 months ]
   Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), < 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.

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 and biochemically confirmed recurrent or progressing multiple myeloma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy

  • At least one standard first line therapy failure
• No localized plasmacytoma or plasmacytosis limited to the bone marrow
• Evidence of tumor by MRI or CT scan
• Presence of myeloma proteins in serum and urine, including Bence-Jones proteins

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3
• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal
• No hepatic insufficiency

Renal:

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

Cardiovascular:

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

Pulmonary:

• No severe 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 serious medical or psychiatric disorders
• No active infections

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulating agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks)

Surgery:

• Must be recovered from prior surgery

Other:

• Prior cytodifferentiating agent allowed
• No prior antineoplaston therapy

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: NCT00003511
• Other Study ID Numbers: CDR0000066554; BC-MM-2 ( Other Identifier: Burzynski Research Institute )
• First Posted: January 27, 2003
• Results First Posted: January 28, 2021
• Last Update Posted: June 9, 2021
• Last Verified: May 2021

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:

Stage I multiple myeloma; Stage II multiple myeloma; Stage III multiple myeloma

Additional relevant MeSH terms:

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