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

• Sponsor: Burzynski Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003499
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Actual Duration (Months): 90.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low-Grade Lymphoma	Drug: Antineoplaston therapy (Atengenal + Astugenal)	Phase 2

Detailed Description

Low-grade Non-Hodgkin's Lymphoma 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 Low-grade Non-Hodgkin's Lymphoma, 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 Low-grade Non-Hodgkin's Lymphoma.

• 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
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Low Grade
• Actual Study Start Date: Mar 6, 1996
• Actual Primary Completion Date: Sep 13, 2003
• Actual Study Completion Date: Sep 13, 2003

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 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.; Other Names: A10 (Atengenal); AS2-1 (Astugenal)ANP

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Objective Response [12 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.

Secondary Outcome Measures

1. Percentage of Participants Who Survived [6 months, 12 months, 24 months, 36 months, 48 months, 60 months]

   6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Burzynski Research Institute
• Burzynski Clinic

Publications

None provided.

• Responsible Party: Burzynski Research Institute
• ClinicalTrials.gov Identifier: NCT00003499
• Other Study ID Numbers: CDR0000066538; BC-LY-6
• First Posted: Jan 27, 2003
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Low-grade non-Hodgkin's lymphoma
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin

Study Results

Participant Flow

Recruitment Details	Thirty-one patients were recruited between March 1996 and November 2002. All study subjects were seen at the Burzynski Clinic in Houston TX

Arm/Group Title	Antineoplaston Therapy
Arm/Group 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. Antineoplaston therapy (Atengenal + Astugenal): 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.
Period Title: Overall Study
STARTED	31
COMPLETED	23
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Antineoplaston Therapy
Arm/Group 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. Antineoplaston therapy (Atengenal + Astugenal): 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.
Overall Participants	31
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	54.2
Sex: Female, Male (Count of Participants)
Female	15 48.4%
Male	16 51.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Objective Response
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antineoplaston Therapy
Arm/Group 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. Antineoplaston therapy (Atengenal + Astugenal): 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.
Measure Participants	23
Complete Response	1 3.2%
Partial Response	2 6.5%
Stable Disease	14 45.2%
Progressive Disease	6 19.4%

2. Secondary Outcome

Title	Percentage of Participants Who Survived
Description	6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Time Frame	6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Outcome Measure Data

Analysis Population Description

All study subjects receiving any Antineoplaston therapy

Arm/Group Title	Antineoplaston Therapy
Arm/Group 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. Antineoplaston therapy (Atengenal + Astugenal): 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.
Measure Participants	31
6 months overall survival	29 93.5%
12 months overall survival	28 90.3%
24 months overall survival	21 67.7%
36 months overall survival	17 54.8%
48 months overall survival	14 45.2%
60 months overall survival	11 35.5%

Adverse Events

Time Frame	6 years, 8 months
Adverse Event Reporting Description	Adverse event data was collected through regular patient assessment and regular laboratory testing
Arm/Group Title	Antineoplaston Therapy
Arm/Group 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. Antineoplaston therapy (Atengenal + Astugenal): 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.
All Cause Mortality
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	10/31 (32.3%)
Blood and lymphatic system disorders
Hemoglobin	1/31 (3.2%)
Cardiac disorders
Left ventricular systolic dysfunction	1/31 (3.2%)
General disorders
Pain: Oral cavity	1/31 (3.2%)
Infections and infestations
Infection (documented clinically): Blood	3/31 (9.7%)
Nervous system disorders
Seizure	1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Lung (pneumonia)	2/31 (6.5%)
Dyspnea (shortness of breath)	1/31 (3.2%)
Other (Not Including Serious) Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	31/31 (100%)
Blood and lymphatic system disorders
Hemoglobin	7/31 (22.6%)
Leukocytes (total WBC)	2/31 (6.5%)
Lymphopenia	2/31 (6.5%)
Neutrophils/granulocytes (ANC/AGC)	3/31 (9.7%)
Platelets	4/31 (12.9%)
Cardiac disorders
Cardiac Arrhythmia	5/31 (16.1%)
Ear and labyrinth disorders
Tinnitus	3/31 (9.7%)
Gastrointestinal disorders
Diarrhea	8/31 (25.8%)
Dry mouth/salivary gland (xerostomia)	2/31 (6.5%)
Nausea	22/31 (71%)
Taste alteration (dysgeusia)	2/31 (6.5%)
Vomiting	10/31 (32.3%)
General disorders
Central venous catheter infection	2/31 (6.5%)
Central venous catheter - non-functional	2/31 (6.5%)
Fatigue (asthenia, lethargy, malaise)	20/31 (64.5%)
Fever	5/31 (16.1%)
Rigors/chills	5/31 (16.1%)
Edema	16/31 (51.6%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	10/31 (32.3%)
Infections and infestations
Infection (documented clinically): Blood	6/31 (19.4%)
Infection (documented clinically): Upper airway NOS	2/31 (6.5%)
Lung (pneumonia)	3/31 (9.7%)
Mucosa	3/31 (9.7%)
Skin	5/31 (16.1%)
Upper airway	8/31 (25.8%)
Investigations
Alkaline phosphatase	2/31 (6.5%)
Hyperbilirubinemia	3/31 (9.7%)
Hyperglycemia	5/31 (16.1%)
Hypernatremia	22/31 (71%)
Hypocalcemia	4/31 (12.9%)
Hypochloremia	2/31 (6.5%)
Hypoglycemia	3/31 (9.7%)
Hypokalemia	22/31 (71%)
Hypomagnesemia	2/31 (6.5%)
SGOT	8/31 (25.8%)
SGPT	4/31 (12.9%)
Musculoskeletal and connective tissue disorders
Pain: Joint	9/31 (29%)
Pain: Muscle	3/31 (9.7%)
Nervous system disorders
Confusion	2/31 (6.5%)
Dizziness	9/31 (29%)
Mood alteration	3/31 (9.7%)
Neuropathy: sensory	2/31 (6.5%)
Somnolence/depressed level of consciousness	9/31 (29%)
Speech impairment	2/31 (6.5%)
Pain: Head/headache	10/31 (32.3%)
Renal and urinary disorders
Hemorrhage, GU	2/31 (6.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	9/31 (29%)
Skin and subcutaneous tissue disorders
Hyperepidermisation	2/31 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.