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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003517
First Posted: January 27, 2003
Last Update Posted: July 10, 2013
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:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.


Condition Intervention Phase
Adenocarcinoma of the Prostate Stage III Prostate Cancer Stage IV Prostate Cancer Recurrent Prostate Cancer Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Drug: bicalutamide Drug: flutamide Drug: leuprolide acetate Procedure: alternative product therapy Procedure: antiandrogen therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy Procedure: endocrine therapy Procedure: hormone therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 0
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy.

Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven localized, regional, or metastatic adenocarcinoma of the prostate
  • Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy
  • Measurable tumors or tumor markers
  • Bone metastases allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • No chronic renal failure
  • 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

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 infections or fever
  • No other prior or concurrent second malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior investigational clinical trial
  • No other concurrent treatment for metastatic prostate cancer
  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): NCT00003517


Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00003517     History of Changes
Other Study ID Numbers: BC-PR-6
CDR0000066560 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: July 10, 2013
Last Verified: December 2006

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hormones
Leuprolide
Flutamide
Bicalutamide
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists