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Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003497
First Posted: January 27, 2003
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Burzynski Research Institute
November 1, 1999
January 27, 2003
September 28, 2017
August 1998
May 12, 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003497 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer

Current therapies for Stage IV non-small cell 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.

Stage IV non-small cell lung cancers 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.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Stage IV non-small cell 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 non-small cell lung cancer.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stage IV Non-small Cell Lung Cancer
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
Other Name: A10 (Atengenal); AS2-1 (Astugenal)
Experimental: Antineoplastons
Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
May 12, 2004
May 12, 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003497
CDR0000066536
BC-LA-10 ( Other Identifier: Burzynski Research Institute )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Burzynski Research Institute
Burzynski Research Institute
Not Provided
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
Burzynski Research Institute
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP