Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer

NCT00003533 | Terminated Phase 2 FDA Drug

• 2 other identifiers: CDR0000066580BC-PR-4
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

adenocarcinoma of the prostate

Study Arms (1)

Antineoplaston therapy

EXPERIMENTAL

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)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

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.

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

Antineoplaston therapy

Eligibility Criteria

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

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

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: February 27, 1996
• Primary Completion: December 31, 1999
• Study Completion: December 31, 1999
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)