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Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00003516
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Detailed Description:

Stage III or Stage IV Prostate Cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Stage III or Stage IV Prostate Cancer, 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 Stage III or Stage IV Prostate Cancer.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate
Actual Study Start Date : March 27, 1996
Actual Primary Completion Date : March 18, 2004
Actual Study Completion Date : March 18, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Antineoplastons
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.
Drug: Antineoplaston therapy (Atengenal + Astugenal)
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.
Other Name: A10 (Atengenal); AS2-1 (Astugenal)





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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage III or IV adenocarcinoma of the prostate not potentially curable by surgery or radiotherapy
  • Measurable tumors or tumor markers
  • No response to antiandrogen withdrawal

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.5 mg/dL
  • SGOT no greater than 2 times normal
  • No hepatic failure

Renal:

  • BUN less than 60 mg/dL
  • Creatinine no greater than 2.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min
  • Blood ammonia normal
  • No chronic renal failure

Cardiovascular:

  • No severe heart disease

Pulmonary:

  • No severe lung disease

Other:

  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No serious active infection or fever
  • No other concurrent serious disease
  • No other prior or concurrent malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy and recovered
  • Prior corticosteroids for at least 2 months allowed, but must be on stable or decreasing dose during study participation

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered

Other:

  • At least 4 weeks since prior experimental clinical trial
  • No other concurrent therapy for metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003516


Locations
United States, Texas
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

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003516     History of Changes
Other Study ID Numbers: CDR0000066559
BC-PR-5 ( Other Identifier: Burzynski Research Institute )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Stage III or Stage IV Prostate Cancer Stage III
Stage III or Stage IV Prostate Cancer Stage IV

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases