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TerminatedPhase 2NCT00003508
Official study title

Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

Study summary

Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Mesothelioma.

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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 forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 27, 2021 · 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

01
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)
02
Explore related studies

How this study is categorized

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

Cancer type
Mesothelioma→
03
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 mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Evidence of disease by CT scan or MRI PATIENT CHARACTERISTICS: Age:
  • 1 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 and SGPT no greater than 5 times upper limit of normal
  • Hepatic function adequate 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 uncontrolled hypertension
  • No history of congestive heart failure
  • No cardiovascular conditions that contraindicate high dosages of sodium Pulmonary:
  • No serious 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
  • Not at high medical or psychiatric risk
  • No nonmalignant systemic disease
  • 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 Endocrine therapy:
  • Concurrent corticosteroids allowed Radiotherapy:
  • At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered Surgery:
  • Recovered from prior surgery Other:
  • Prior cytodifferentiating agents allowed
  • No prior antineoplastons
  • No other concurrent antineoplastic agents

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

04
Study sites

U.S. locations

  • Burzynski ClinicHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 27, 2021. Always confirm current availability with the study team.

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