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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00003495
Other study ID # CDR0000066534
Secondary ID BC-LA-06
Status Terminated
Phase Phase 2
First received November 1, 1999
Last updated September 26, 2017
Start date March 27, 1996
Est. completion date November 4, 2003

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 or Recurrent 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 or Recurrent Lung Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV or Recurrent Lung Cancer.


Description:

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV or Recurrent Lung Cancer 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 or Recurrent 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 or Recurrent 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 7
Est. completion date November 4, 2003
Est. primary completion date November 4, 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or stage IV squamous 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/mm3

- Platelet count at least 50,000/mm3

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

- No serious active infections

- No other serious concurrent 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 since 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Antineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV or Recurrent 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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