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Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00003474
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : December 13, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

November 1, 1999
January 27, 2003
July 27, 2017
December 13, 2017
March 22, 2018
March 14, 1996
June 21, 2003   (Final data collection date for primary outcome measure)
Number of Participants With Objective Response [ Time Frame: 12 months ]
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.
Not Provided
Complete list of historical versions of study NCT00003474 on ClinicalTrials.gov Archive Site
Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma Multiforme of the Brain
Drug: Antineoplaston therapy (Atengenal + Astugenal)

Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Other Name: A10 (Atengenal); AS2-1 (Astugenal)
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
June 21, 2003
June 21, 2003   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)

    • Measurable disease by MRI or CT scan
  • Brain stem tumor is excluded
  • 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 2,000/mm3
  • Platelet count at least 50,000/mm3

Hepatic:

  • No liver failure
  • Bilirubin no greater than 2.5 mg/dL
  • SGOT/SGPT no greater than 5 times upper limit

Renal:

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

Cardiovascular:

  • 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 COPD)

Other:

  • Not pregnant or nursing
  • Fertile patients must use adequate contraception during and for 4 weeks after study
  • No active infection
  • No other serious medical or psychiatric conditions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since chemotherapy (unless radiologically proven progression)
  • At least 6 weeks since nitrosoureas

Endocrine therapy:

  • Corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since radiotherapy (unless radiologically proven progression)

Surgery:

  • Recovered from prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003474
CDR0000066511
BRI-BT-20 ( Other Identifier: Burzynski Research Institute )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Plan to Share IPD: No
Burzynski Research Institute
Burzynski Research Institute
Not Provided
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
Burzynski Research Institute
March 2018

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