Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas

Mixed Gliomas Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003473
• Other study ID #: CDR0000066510
• Secondary ID: BC-BT-18
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: December 18, 2017
• Start date: March 1996
• Est. completion date: August 2007

Study information

• Verified date: December 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with recurrent or refractory mixed gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

Description:

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas 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 with recurrent or refractory mixed gliomas.

OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory mixed gliomas 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. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy

• Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry

• Must have received and failed standard therapy

• 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

Related Conditions & MeSH terms

• Glioma
• Mixed Gliomas

Intervention

Drug:
• Atengenal
Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
• Astugenal
Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Objective Response	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.	12 months
Secondary	Percentage of Participants Who Survived	6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival	6 months, 12 months, 24 months, 36 months, 48 months, 60 months

External Links

•   Burzynski Clinic
•   Burzynski Research Institute