NCT00003494

Brief Summary

Current therapies for Recurrent or 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 Recurrent or Stage IV Lung Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Stage IV Lung Cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1996

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

January 30, 2018

Conditions

Bronchial Alveolar; Tumor

Keywords

Bronchial Alveolar Cancer RecurrentBronchial Alveolar Cancer Stage IV

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 Recurrent or Stage IV Lung 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

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or stage IV bronchoalveolar cell lung cancer unlikely to have a curative response to existing standard regimens * Measurable disease by MRI or CT scan * At least 2 cm in diameter 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 insufficiency * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No severe heart disease * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No serious active infections * No other concurrent serious disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulating 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 Surgery: * Recovered from prior surgery Other: * No prior antineoplaston therapy * 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

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

antineoplaston A10antineoplaston AS 2-1

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

March 26, 1996

Primary Completion

May 26, 2002

Study Completion

May 26, 2002

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)