Antineoplaston Therapy in Treating Patients With Colon Cancer

NCT00003486 | Withdrawn Phase 2

• 2 other identifiers: BC-CO-3CDR0000066524
• 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 colon cancer.

Conditions

Stage IV Colon Cancer; Recurrent Colon Cancer; Adenocarcinoma of the Colon

Interventions

antineoplaston A10 DRUG

antineoplaston AS2-1 DRUG

alternative product therapy PROCEDURE

biological therapy PROCEDURE

biologically based therapies PROCEDURE

cancer prevention intervention PROCEDURE

complementary and alternative therapy PROCEDURE

differentiation therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists * Measurable disease by MRI or CT scan * Metastatic or unresectable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal failure Cardiovascular: * No chronic heart failure * No uncontrolled hypertension Pulmonary: * No serious lung disease, such as chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No active infection * No serious malabsorption syndromes * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) Surgery: * No prior extensive stomach or intestinal surgery Other: * Prior cytodifferentiating agent allowed * No prior antineoplaston therapy * No other concurrent anticancer therapy

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

Colonic Neoplasms

Interventions

antineoplaston A10; antineoplaston AS 2-1; Biological Therapy; Complementary Therapies

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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)