Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma

Oligodendroglioma, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003472
• Other study ID #: CDR0000066509
• Secondary ID: BC-BT-17
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 7, 2018
• Start date: May 1996
• Est. completion date: September 2007

Study information

• Verified date: March 2018
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.

Description:

OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive oligodendrogliomas 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 with recurrent/progressive oligodendrogliomas, 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/progressive oligodendrogliomas.

• 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: Terminated
• Enrollment: 13
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy

• Measurable tumor by MRI scan performed within two weeks prior to study entry

• Tumor must be at least 5 mm

• No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

• SGOT/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 severe heart disease

• No uncontrolled hypertension

• No history of congestive heart failure

• No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No severe lung disease (e.g., chronic obstructive pulmonary disease)

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 4 weeks after study participation

• No serious active infections

• No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• At least 4 weeks since prior immunotherapy

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 8 weeks since prior radiotherapy

Surgery:

• Recovered from any prior surgery

Other:

• No prior antineoplaston therapy

Related Conditions & MeSH terms

• Oligodendroglioma
• Oligodendroglioma, Adult

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Adults with a recurrent/progressive Oligodendroglioma 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