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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00003491
Other study ID # CDR0000066530
Secondary ID BC-LA-03
Status Terminated
Phase Phase 2
First received November 1, 1999
Last updated September 27, 2017
Start date March 20, 1996
Est. completion date July 31, 1998

Study information

Verified date September 2017
Source Burzynski Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

OVERVIEW: This is a single arm, open-label study in which patients with 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 to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with 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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date July 31, 1998
Est. primary completion date July 31, 1998
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antineoplaston therapy (Atengenal + Astugenal)
Patients with 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.

Locations

Country Name City State
United States Burzynski Clinic Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

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