We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003533
First Posted: January 27, 2003
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Burzynski Research Institute
  Purpose

Current therapies for Metastatic Pancreatic 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 Metastatic Pancreatic Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic Pancreatic Cancer.


Condition Intervention Phase
Metastatic Prostate Cancer Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Study Type: Interventional
Study Design: 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 Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Burzynski Research Institute:

Enrollment: 12
Actual Study Start Date: February 27, 1996
Study Completion Date: December 31, 1999
Primary Completion Date: December 31, 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Metastatic Pancreatic Cancer 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 Name: A10 (Atengenal); AS2-1 (Astugenal)ANP

Detailed Description:

Metastatic Pancreatic Cancer 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 Metastatic Pancreatic 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 Metastatic Pancreatic Cancer.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

DISEASE CHARACTERISTICS:

  • Histologically proven incurable, metastatic, hormone-refractory adenocarcinoma of the prostate that is unlikely to respond to existing therapy

    • Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
    • Stage D2

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • WBC at least 2,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • No hepatic insufficiency
  • Bilirubin no greater than 2.5 mg/dL
  • SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No known chronic heart failure
  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

  • No serious lung disease, such as severe chronic obstructive pulmonary disease

Other:

  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • Not a high medical or psychiatric risk
  • No concurrent nonmalignant systemic disease
  • No active infection

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 (unless progression documented upon discontinuation of hormones)
  • Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months before study entry

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Recovered from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  Contacts and Locations
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): NCT00003533


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
  More Information

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003533     History of Changes
Other Study ID Numbers: CDR0000066580
BC-PR-4 ( Other Identifier: Burzynski Research Institute )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: December 12, 2017
Last Verified: December 2017
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:
adenocarcinoma of the prostate

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