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Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003489
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: July 2004

November 1, 1999
July 23, 2008
August 1998
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Complete list of historical versions of study NCT00003489 on ClinicalTrials.gov Archive Site
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Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck

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 advanced head and neck cancer.

OBJECTIVES:

  • Provide treatment with antineoplastons A10 and AS2-1 to patients with incurable cancer of the head and neck.
  • 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 six times per day until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for 8 months beyond CR.

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
Head and Neck 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 cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists

    • Metastatic disease OR incurable with surgery or radiation
  • 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:

  • 16 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 2.5 mg/dL

Renal:

  • No renal insufficiency
  • Creatinine no greater than 2.5 mg/dL
  • No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No chronic heart failure
  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No other cardiovascular conditions that contraindicate high dosages of sodium

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

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 therapy

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered

Surgery:

  • See Disease Characteristics

Other:

  • Prior cytodifferentiating agents allowed
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003489
CDR0000066527, BC-HN-2
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Burzynski Research Institute
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Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
July 2004

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