TerminatedPhase 2NCT00003491

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

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.

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

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorBurzynski Research Institute
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.

03
Public criteria

Who may be able to participate

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.

04
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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