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”

RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with recurrent or refractory mixed gliomas.

OBJECTIVES: - Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy. - Assess the response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues in the absence of toxicity and disease progression.

Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, then annually thereafter.

PROJECTED ACCRUAL: This study will accrue 20-40 patients.

Intervention(s) in this Clinical Trial

• Drug: antineoplaston A10
• Drug: antineoplaston AS2-1

Primary Measures

• Response rate based on tumor measurements taken at 12 weeks
  • Safety Issue?: No

Secondary Measures

• Survival at 1, 2, and 5 years from the start of treatment
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable primary mixed glioma that is progressive, persistent, or recurrent following initial standard therapy, including radiation therapy
• Measurable disease by CT scan or MRI
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Burzynski Research Institute Other

Overall Clinical Trial Officials and Contacts

Stanislaw R. Burzynski, MD, PhD Study Chair Burzynski Research Institute  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003473

Study ID Number: CDR0000066510

ClinicalTrials.gov Identifier: NCT00003473

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database