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

NCT00003516 | Terminated Phase 2 FDA Drug

• 2 other identifiers: CDR0000066559BC-PR-5
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Stage III or Stage IV Prostate Cancer Stage III; Stage III or Stage IV Prostate Cancer Stage IV

Study Arms (1)

Antineoplastons

EXPERIMENTAL

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)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)

Antineoplastons

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

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

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 27, 1996
• Primary Completion: March 18, 2004
• Study Completion: March 18, 2004
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)