Clinical trial NCT00003473: Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Official title: Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mixed Gliomas
Keywords: recurrent adult mixed glioma
refractoy adult mixed glioma
Lead sponsor: Burzynski Research Institute
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Objective Response
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants Who Survived
timeFrame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Burzynski Clinic
state: Texas
Study officials:
affiliation: Burzynski Research Institute
name: Stanislaw R. Burzynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: