Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

Study 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 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAntineoplaston therapy (Atengenal + Astugenal)

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 29, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Burzynski Research Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Burzynski Research Institute
Interventions being studied: Drug: Antineoplaston therapy (Atengenal + Astugenal)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS:
Histologically confirmed stage IV adenocarcinoma of the lung that is unlikely to respond to existing therapy and for which no curative therapy exists
Measurable disease by MRI or CT scan 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:
No hepatic insufficiency
Bilirubin no greater than 2.5 mg/dL
SGOT/SGPT no greater than 5 times upper limit of normal 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 chronic heart disease that would preclude study treatment
No history of chronic heart failure
No uncontrolled hypertension
No history of congestive heart failure
No history of cardiovascular conditions that contraindicate high dosages of sodium Pulmonary:
No lung disease that would preclude study treatment
No serious lung disease (e.g., severe chronic obstructive pulmonary disease) Neurologic:
No neurological disease that would preclude study treatment Other:
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No gastrointestinal or psychiatric disease that would preclude study treatment
No active infection 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 Surgery:
Not specified Other:
Prior cytodifferentiating agents allowed
No prior antineoplaston therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Burzynski ClinicHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2017. Always confirm current availability with the study team.

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