Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

CDR0000066511


NCT ID:

NCT00003474


Secondary ID:

BRI-BT-20


Study Acronym:


Brief Title:

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


Official Title:

Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Burzynski Research Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stanislaw R. Burzynski, MD, PhD
Principal Investigator
Burzynski Research Institute

Study Dates

Start Date:March 14, 1996
Completion Date:June 21, 2003
Completion Type:Actual
Primary Completion Date:June 21, 2003
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 7, 2018
First Received Date:November 1, 1999
First Results Date:July 27, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With Objective Response
Time Frame:12 months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Percentage of Participants Who Survived
Time Frame:6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Safety Issues:False
Description:6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Study Interventions

Intervention Type:Drug
Name:Antineoplaston therapy (Atengenal + Astugenal)
Description: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.
Arm Name:Antineoplaston therapy
Other Name:A10 (Atengenal); AS2-1 (Astugenal)

Study Arms

Study Arm Type:Experimental
Arm Name:Antineoplaston therapy
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Burzynski Research Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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