Antineoplaston Therapy in Treating Patients With Multiple Myeloma

NCT00003511 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CDR0000066554BC-MM-2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  36 months

Study Arms (1)

Antineoplaston therapy

EXPERIMENTAL

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)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)

Antineoplaston therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Conditions

Multiple Myeloma

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: S. R. Burzynski, MD, PhD
• Organization: Burzynski Research Institute, Inc.

srb@burzynskiclinic.com

713-335-5664

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 4, 1996
• Primary Completion: October 21, 1999
• Study Completion: October 21, 1999
• Last Updated: June 9, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)