Lung Cancer Clinical Trial

Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer

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.

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Full Description

Recurrent or 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 Recurrent or 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 Recurrent or 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00003494

Recruitment Status:

Terminated

Sponsor:

Burzynski Research Institute

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There is 1 Location for this study

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Burzynski Clinic
Houston Texas, 77055, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00003494

Recruitment Status:

Terminated

Sponsor:


Burzynski Research Institute

How clear is this clinincal trial information?

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