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Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
This study is currently recruiting participants.
Study NCT00003470   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: June 9, 2009   History of Changes

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 ]
Response rate based on tumor measurements taken at 12 weeks
Complete list of historical versions of study NCT00003470 on ClinicalTrials.gov Archive Site
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
Survival at 1, 2, and 5 years from the start of treatment
 
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma

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 anaplastic astrocytoma that has not responded to previous treatment.

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable anaplastic astrocytoma who experienced disease progression or recurrence or have residual disease after standard therapy.
  • Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: 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, every 3 months for the second year, every 3-4 months during the third and fourth years, every 4-6 months during the fifth year, and yearly thereafter.

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

Phase II
Interventional
Treatment, Open Label
Brain and Central Nervous System Tumors
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
 
December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable anaplastic astrocytoma that has progressed, recurred, or persisted after completion of standard therapy (including radiation therapy)
  • Measurable disease by MRI or CT scan
  • Tumor must be at least 5 mm
  • Must have received prior standard therapy (i.e., radiation therapy, chemotherapy, immunotherapy, or cytodifferentiating agent)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No serious lung disease such as severe chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No active infection
  • No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Fully recovered from any prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
Both
18 Years and older
No
 
United States
 
NCT00003470
Stanislaw R. Burzynski, Burzynski Clinic
CDR0000066507, BC-BT-15
Burzynski Research Institute
 
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