Antineoplaston Therapy in Treating Patients With Multiple Myeloma

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Antineoplaston therapy (Atengenal + Astugenal)

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Stage I multiple myeloma, Stage II multiple myeloma, Stage III multiple myeloma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Burzynski Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antineoplaston therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00003511

First Posted

November 1, 1999

Last Updated

May 17, 2021

Sponsor

Burzynski Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00003511

Brief Title

Antineoplaston Therapy in Treating Patients With Multiple Myeloma

Official Title

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

April 4, 1996 (Actual)

Primary Completion Date

October 21, 1999 (Actual)

Study Completion Date

October 21, 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Burzynski Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Stage I multiple myeloma, Stage II multiple myeloma, Stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antineoplaston therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Antineoplaston therapy (Atengenal + Astugenal)

Other Intervention Name(s)

A10 (Atengenal); AS2-1 (Astugenal)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable

Description

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.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stanislaw R. Burzynski, MD, PhD

Organizational Affiliation

Burzynski Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Burzynski Clinic

City

Houston

State/Province

Texas

ZIP/Postal Code

77055-6330

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Links:

URL

http://www.burzynskiresearch.com

Description

Burzynski Research Institute

URL

http://www.burzynskiclinic.com

Description

Burzynski Clinic

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial