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Antineoplaston

Antineoplastons for Prostate Cancer

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

Current therapies for Stage III or Stage IV Prostate Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage III or Stage IV Prostate Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage III or Stage IV Prostate Cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 2 trial • 34 Patients • NCT00003458

79%

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

Pruritus/itching

Anorexia

Dry mouth/salivary gland (xerostomia)

Hemorrhage, GU: Bladder

Hemorrhage, GU: Urinary NOS

Petechiae

Infection (documented clinically): Mucosa

Albumin, serum-low (hypoalbuminemia)

Hypercalcemia

Hypomagnesemia

Diplopia

Pain: Muscle

Pain: Back

Rigors/chills

Weight gain

Central Venous Catheter Infection

Hemorrhage, CNS

Platelets

Bruising (in absence of Grade 3 or 4 thrombocytopenia)

Distension/bloating, abdominal

Taste alteration (dysgeusia)

Infection (documented clinically): Lung (pneumonia)

Hypermagnesemia

Memory impairment

Pain: Chest wall

Pain: Middle ear

Incontinence, urinary

Neuropathy: CN III Pupil, upper eyelid, extra ocular movements

Neuropathy: cranial: CN VI Lateral deviation of eye

Neuropathy: cranial: CN VII Motor-face; Sensory-taste

Neuropathy: sensory

Pain: Stomach

Thrombosis/embolism - Central venous catheter

Hematoma

Infection (documented clinically): Skin (cellulitis)

Hyperntremia

Hydrocephalus

100%

80%

60%

40%

20%

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: AntineoplastonsExperimental Treatment1 Intervention

Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antineoplaston therapy (Atengenal + Astugenal)

1996

Completed Phase 2

~350

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