Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer

Colon Cancer Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Colon

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003485
• Other study ID #: CDR0000066523
• Secondary ID: BC-CO-02
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 26, 2017
• Start date: April 10, 1996
• Est. completion date: May 11, 2003

Study information

• Verified date: September 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for metastatic or unresectable Colon 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 or unresectable Colon Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer

Description:

OVERVIEW: This is a single arm, open-label study in which patients with metastatic or unresectable Colon Cancer cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).

• To determine the safety and tolerance of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer.

• To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 11, 2003
• Est. primary completion date: May 11, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists

• Metastatic or unresectable disease

• Measurable disease by CT scan or MRI

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

• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No 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 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 other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulatory agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier)

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agent allowed

• No prior antineoplaston therapy

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• antineoplaston A10, antineoplaston AS2-1 (ANP)
Patients with metastatic or unresectable Colon 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.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States,