Clinical Trial: Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer

This study is no longer recruiting patients.

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)

Purpose

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 recurrent or stage IV lung cancer.

Condition Treatment or Intervention Phase
recurrent non-small cell lung cancer
Squamous Cell Lung Cancer
stage IV non-small cell lung cancer
 Drug: antineoplaston A10
 Drug: antineoplaston AS2-1
 Procedure: biological response modifier therapy
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent or Stage IV Squamous Cell Lung Cancer

Further Study Details: 

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or stage IV squamous cell lung cancer.
  • 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 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months during the first year and then every 3 months for the second year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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:

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:

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

Surgery:

  • Recovered from prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed

Location Information


Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States

Study chairs or principal investigators

Stanislaw R. Burzynski, MD, PhD,  Study Chair,  Burzynski Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066534; BC-LA-6
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003495
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005