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NCT00003498

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

Terminated Phase 2 Results posted Last updated 22 January 2021
What this trial tests

Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Non Hodgkin Lymphoma in 5 participants. Terminated before completion.

Timeline
13 October 1997
Primary endpoint
2 February 2007
2 February 2007

Quick facts

Lead sponsorBurzynski Research Institute
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date13 October 1997
Primary completion2 February 2007
Estimated completion2 February 2007
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Burzynski Research Institute

Who can join

Adults 18 to 99, any sex, with Non Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With an Objective Response, Stable Disease, or Progressive Disease Primary · 5 months

An objective response is defined as a complete or partial response. A complete response is complete disappearance of all tumor by physical examination and radiographic studies and bone marrow involvement, if appropriate, for a minimum of four weeks. A partial response is a \> 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates \< 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions comp

Complete Response
GroupValue95% CI
Antineoplaston Therapy0
Partial Response
GroupValue95% CI
Antineoplaston Therapy0
Stable Disease
GroupValue95% CI
Antineoplaston Therapy0
Progressive Disease
GroupValue95% CI
Antineoplaston Therapy1

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 years, 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Antineoplaston Therapy
Serious: 1/5 (20%)
Deaths:

Serious adverse events (1 terms)

ReactionSystemAntineoplaston Therapy
Hemorrhage/Bleeding - Other (Inguinal region)Skin and subcutaneous tissue disorders
Other adverse events (26 terms — click to expand)

ReactionSystemAntineoplaston Therapy
HypokalemiaInvestigations
HemoglobinBlood and lymphatic system disorders
Leukocytes (total WBC)Blood and lymphatic system disorders
PlateletsBlood and lymphatic system disorders
Alkaline phosphataseInvestigations
HypernatremiaInvestigations
LymphopeniaBlood and lymphatic system disorders
Fatigue (asthenia, lethargy, malaise)General disorders
Edema/Fluid retentionSkin and subcutaneous tissue disorders
Dry mouth/salivary gland (xerostomia)Gastrointestinal disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Hemorrhage, GU: BladderRenal and urinary disorders
Hemorrhage/Bleeding - Other (Inguinal region)Skin and subcutaneous tissue disorders
Albumin, serum-low (hypoalbuminemia)Investigations
HyperbilirubinemiaInvestigations
HyperglycemiaInvestigations
HypocalcemiaInvestigations
HypomagnesemiaInvestigations
ProteinuriaInvestigations
SGOTInvestigations
Musculoskeletal/Soft Tissue - OtherMusculoskeletal and connective tissue disorders
TremorNervous system disorders
Pain: Head/headacheGeneral disorders
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthriaRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Hemorrhage/Bleeding - Other (Inguinal region).

Data from ClinicalTrials.gov NCT00003498 adverse events section.

Sponsor's own description

Current therapies for 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 Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Non-Hodgkin's Lymphoma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Antineoplaston therapy (Atengenal + Astugenal)

Trials testing the same drug.

Other recruiting trials for Non Hodgkin Lymphoma

Currently open trials in the same condition.

Other Burzynski Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00003498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing