Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Stage IV Non-small Cell Lung Cancer
• Interventions: Drug: Antineoplaston therapy (Atengenal + Astugenal)

• Registration Number: NCT00003497
• Lead Sponsor: Burzynski Research Institute

Brief Summary

Current therapies for Stage IV non-small cell lung 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 IV lung cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV lung cancer.

Detailed Description

Stage IV non-small cell lung cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV non-small cell lung 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 Stage IV non-small cell lung cancer.

* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Study Timeline

• Study Start: 1996-08-21
• Primary Completion: 1998-02-02
• Study Completion: 1998-02-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antineoplastons	Antineoplaston therapy (Atengenal + Astugenal)	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.

Trial Locations

Locations (1)

Burzynski Clinic; 🇺🇸 Houston, Texas, United States