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Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer


OBJECTIVES:

- Demonstrate the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients
with non-small cell lung cancer by determining the proportion of patients who
experience an objective tumor response.

- Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive antineoplaston A10 and AS2-1 capsules orally six to seven times a day.
Treatment continues in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then
annually for 2 years.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV non-small cell lung cancer that cannot be cured
with existing therapeutic regimens

- Measurable disease by CT scan or MRI

- Tumor must be at least 2 cm for the lymph nodes located in the head, neck,
axillary, inguinal or femoral areas and at least 0.5 cm for other areas

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 and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/dL

Cardiovascular:

- No chronic heart failure

- No uncontrolled hypertension

Pulmonary:

- No serious lung disease (e.g., severe chronic obstructive pulmonary disease)

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No other serious medical or psychiatric conditions

- No active infection

- No serious malabsorption syndromes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

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 (less than 8 weeks if multiple tumors are
involved) and recovered

Surgery:

- No prior extensive stomach or intestinal surgery

- Recovered from any prior surgery

Other:

- Prior cytodifferentiating agents allowed

- No prior antineoplaston treatment

- No other concurrent treatment for metastatic lung cancer

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066536

NCT ID:

NCT00003497

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330