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

November 1, 1999
June 9, 2009
March 1996
December 2011   (final data collection date for primary outcome measure)
Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003473 on ClinicalTrials.gov Archive Site
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00003473
CDR0000066510, BC-BT-18
Not Provided
Stanislaw R. Burzynski, Burzynski Clinic
Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
June 2009

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