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Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003491
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2004

November 1, 1999
July 23, 2008
August 1998
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Complete list of historical versions of study NCT00003491 on ClinicalTrials.gov Archive Site
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Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Lung

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have stage IV lung cancer.

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable adenocarcinoma of the lung.
  • Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

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

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003491
CDR0000066530, BC-LA-3
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Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
April 2004

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