Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

Phase 2

Terminated

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

• Registration Number: NCT00003492
• Lead Sponsor: Burzynski Research Institute

Brief Summary

Current therapies for Stage IV 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 Pancreatic 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 Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV 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 Lung 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. Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

Study Timeline

• Study Start: 1996-04-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-12-01
• Study Completion: 2000-12-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Results First Submitted: 2020-11-10
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Results First Posted: 2020-12-16
• Last Update Posted: 2020-12-16

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
Antineoplaston therapy	Antineoplaston therapy (Atengenal + Astugenal)	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.

Primary Outcome Measures

Name	Time	Method
Objective Response or Stable Disease	16 months	An objective response is a complete or partial response. A complete response is complete disappearance of all tumors by physical examination and radiographic studies for a minimum duration of four weeks. A partial response is \> 50% reduction in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of four weeks. Stable disease indicates \> 50% change in the sum of the products of the greatest perpendicular diameters of all measurable lesions compared to the corresponding baseline evaluation, for a minimum of twelve weeks.

Trial Locations

Locations (1)

Burzynski Clinic; 🇺🇸 Houston, Texas, United States