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
  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 advanced head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003489

Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003489     History of Changes
Other Study ID Numbers: CDR0000066527, BC-HN-2
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV salivary gland cancer
recurrent salivary gland cancer
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014