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

NCT00003517 | Withdrawn Phase 2

• 2 other identifiers: BC-PR-6CDR0000066560
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma of the Prostate; Stage III Prostate Cancer; Stage IV Prostate Cancer; Recurrent Prostate Cancer

Interventions

antineoplaston A10 DRUG

antineoplaston AS2-1 DRUG

bicalutamide DRUG

flutamide DRUG

leuprolide acetate DRUG

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 PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

antineoplaston A10; antineoplaston AS 2-1; bicalutamide; Flutamide; Leuprolide; Androgen Antagonists; Biological Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (1)