Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

NCT00003499 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CDR0000066538BC-LY-6
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.

Conditions

Low-Grade Lymphoma

Keywords

Low-grade non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response

  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.

  12 months

Secondary Outcomes (1)

• Percentage of Participants Who Survived

  6 months, 12 months, 24 months, 36 months, 48 months, 60 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 Low-grade non-Hodgkin's lymphoma 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)ANP

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 proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC greater than 2,000/mm\^3 * Platelet count greater than 20,000/mm\^3 Hepatic: * Bilirubin normal Renal: * Creatinine normal * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No serious active infections PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since immunotherapy and recovered * No concurrent immunomodulating agents (e.g., interferon, interleukin-2) Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * At least 4 weeks since prior corticosteroids * No concurrent corticosteroids Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No prior antineoplaston therapy * No other concurrent antineoplastic agents * No concurrent antibiotics, antifungals, or antivirals

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

Lymphoma, Non-Hodgkin

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; 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: March 6, 1996
• Primary Completion: September 13, 2003
• Study Completion: September 13, 2003
• Last Updated: November 24, 2020
• Results First Posted: April 16, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)