Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003473
First received: November 1, 1999
Last updated: June 9, 2009
Last verified: June 2009
  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 is studying how well antineoplaston therapy works in treating patients with recurrent or refractory mixed gliomas.


Condition Intervention Phase
Brain and Central Nervous System Tumors
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 Adult Patients With Mixed Glioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 1996
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy.
  • Assess the response, 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 in the absence of toxicity and disease progression.

Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, then annually thereafter.

PROJECTED ACCRUAL: This study will accrue 20-40 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable primary mixed glioma that is progressive, persistent, or recurrent following initial standard therapy, including radiation therapy
  • Measurable disease by CT scan or MRI
  • Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2000/mm3
  • Platelet count at least 50,000/mm3

Hepatic:

  • No hepatic insufficiency
  • Bilirubin no greater than 2.5 mg/mL
  • SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No severe lung disease
  • No severe chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No other severe medical illness
  • No nonmalignant systemic disease
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression)

Surgery:

  • Fully recovered from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
  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: NCT00003473

Locations
United States, Texas
Burzynski Clinic Recruiting
Houston, Texas, United States, 77055-6330
Contact: Stanislaw R. Burzynski, MD, PhD    713-335-5697    info@burzynskiclinic.com   
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Stanislaw R. Burzynski, Burzynski Clinic
ClinicalTrials.gov Identifier: NCT00003473     History of Changes
Other Study ID Numbers: CDR0000066510, BC-BT-18
Study First Received: November 1, 1999
Last Updated: June 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult mixed glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014