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| ID | Type | Description | Link |
|---|---|---|---|
| BC-LY-6 | Other Identifier | BRI |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Survived | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burzynski Clinic | Houston | Texas | 77055-6330 | United States |
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| Label | URL |
|---|---|
| Burzynski Research Institute | View source |
| Burzynski Clinic | View source |
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Thirty-one patients were recruited between March 1996 and November 2002. All study subjects were seen at the Burzynski Clinic in Houston TX
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | 12 months |
|
6 years, 8 months
Adverse event data was collected through regular patient assessment and regular laboratory testing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | The hemoglobin was not related to Antineoplaston therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. R. Burzynski, MD, PhD | Burzynski Research Institute, Inc. | 713-335-5664 | srb@burzynskiclinic.com |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C052091 | antineoplaston A10 |
| C092038 | antineoplaston AS 2-1 |
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|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants Who Survived | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival | All study subjects receiving any Antineoplaston therapy | Posted | Number | Percentage of Participants | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months |
|
|
|
| 10 |
| 31 |
| 31 |
| 31 |
|
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | The Left ventricular systolic dysfunction was not related to Antineoplaston therapy. |
|
| Infection (documented clinically): Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | The Infections (documented clinically): Blood werenot related to Antineoplaston therapy. |
|
| Lung (pneumonia) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | The Lung (pneumonias) were not related to Antineoplaston therapy. |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | The Seizure was not related to Antineoplaston therapy. |
|
| Pain: Oral cavity | General disorders | CTCAE (3.0) | Systematic Assessment | The Pain: Oral cavity was not related to Antineoplaston therapy. |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | The Dyspnea (shortness of breath) was not related to Antineoplaston therapy. |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac Arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Central venous catheter infection | General disorders | Institutional | Systematic Assessment |
|
| Central venous catheter - non-functional | General disorders | Institutional | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperepidermisation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | Institutional | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GU | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection (documented clinically): Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection (documented clinically): Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Mucosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Upper airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypernatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypochloremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypoglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| 36 months overall survival |
|
| 48 months overall survival |
|
| 60 months overall survival |
|