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Antineoplaston Therapy in Treating Patients With Ependymoma
Phase 2
Waitlist Available
Led By Stanislaw R. Burzynski, MD, PhD
Research Sponsored by Burzynski Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Awards & highlights
No Placebo-Only Group
Summary
RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma . PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.
Eligible Conditions
- Ependymoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Objective Response
Secondary study objectives
Percentage of Participants Who Survived
Side effects data
From 2014 Phase 2 trial • 34 Patients • NCT0000345879%
Hypokalemia
71%
Fatigue (asthenia, lethargy, malaise)
65%
Somnolence/depressed level of consciousness
62%
Vomiting
62%
Pain: Head/headache
44%
Hemoglobin
44%
Nausea
38%
Hyperglycemia
38%
Non-functional central venous catheter
35%
Leukocytes (total WBC)
35%
Hypernatremia
32%
Hypoglycemia
32%
Fever
29%
Lymphopenia
29%
Proteinuria
29%
SGPT
29%
Ataxia (incoordination)
26%
Diarrhea
24%
Edema/Fluid retention
24%
Hypercholesteremia
21%
Neutrophils/granulocytes (ANC/AGC)
21%
Central venous catheter infection
21%
SGOT
21%
Neuropathy: motor
18%
Alkaline phosphatase
18%
Dizziness
18%
Tremor
18%
Pain: Abdomen NOS
18%
Dyspnea (shortness of breath)
18%
Urinary frequency/urgency
18%
Seizure
15%
Rash/desquamation
15%
Cushingoid appearance
15%
Hemorrhage, pulmonary: Nose
15%
Hypophosphatemia
15%
Uric acid, serum-high (hyperuricemia)
15%
Speech impairment
15%
Pain: Joint
15%
Cough
15%
Infection (documented clinically): Upper airway NOS
12%
Constipation
12%
Opportunistic infection
12%
Bicarbonate, serum-low
12%
Hypertriglyceridemia
12%
Hypocalcemia
12%
Hyponatremia
12%
Confusion
12%
Pain: Extremity-limb
12%
Heartburn/dyspepsia
12%
GGT (gamma-Glutamyl transpeptidase)
12%
Pain: Neck
9%
Pruritus/itching
9%
Anorexia
9%
Dry mouth/salivary gland (xerostomia)
9%
Hemorrhage, GU: Bladder
9%
Hemorrhage, GU: Urinary NOS
9%
Petechiae
9%
Infection (documented clinically): Mucosa
9%
Albumin, serum-low (hypoalbuminemia)
9%
Hypercalcemia
9%
Hypomagnesemia
9%
Diplopia
9%
Pain: Muscle
9%
Pain: Back
9%
Rigors/chills
9%
Weight gain
6%
Central Venous Catheter Infection
6%
Hemorrhage, CNS
6%
Platelets
6%
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
6%
Distension/bloating, abdominal
6%
Taste alteration (dysgeusia)
6%
Infection (documented clinically): Lung (pneumonia)
6%
Hypermagnesemia
6%
Memory impairment
6%
Pain: Chest wall
6%
Pain: Middle ear
6%
Incontinence, urinary
6%
Neuropathy: CN III Pupil, upper eyelid, extra ocular movements
6%
Neuropathy: cranial: CN VI Lateral deviation of eye
6%
Neuropathy: cranial: CN VII Motor-face; Sensory-taste
6%
Neuropathy: sensory
6%
Pain: Stomach
6%
Thrombosis/embolism - Central venous catheter
3%
Hematoma
3%
Infection (documented clinically): Skin (cellulitis)
3%
Hyperntremia
3%
Hydrocephalus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antineoplaston Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Antineoplaston therapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antineoplaston therapy (Atengenal + Astugenal)
1996
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Burzynski Research InstituteLead Sponsor
64 Previous Clinical Trials
795 Total Patients Enrolled
Stanislaw R. Burzynski, MD, PhDPrincipal InvestigatorBurzynski Research Institute
61 Previous Clinical Trials
774 Total Patients Enrolled