Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00003476
• Other study ID #: CDR0000066513
• Secondary ID: BC-BT-22
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 9, 2009
• Start date: March 1996

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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 children with primary malignant brain tumors.

Description:

OBJECTIVES:

• Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with primary malignant brain tumors by determining the proportion of patients who experience an objective tumor response.

• Evaluate the adverse effects of and tolerance to this regimen in these children.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily 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 responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy

• Must have failed prior standard therapy

• No brain stem glioma

• Evidence of tumor by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

• 6 months to 17 years

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 1,500/mm^3

• Platelet count greater than 50,000/mm^3

Hepatic:

• No hepatic failure

• Bilirubin no greater than 2.5 mg/dL

• SGOT/SGPT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

Cardiovascular:

• No severe heart disease

• No uncontrolled hypertension

Pulmonary:

• No severe lung disease

Other:

• Not pregnant or nursing

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

• No serious active infections or fever

• No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulating agents

Chemotherapy:

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

• No concurrent antineoplastic agents

Endocrine therapy:

• Recovered from prior endocrine therapy

• Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered

Surgery:

• At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered

Other:

• No prior antineoplaston therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• antineoplaston A10

• antineoplaston AS2-1

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	Response rate based on tumor measurements at 12 weeks			No
Secondary	Survival at 1, 2, and 5 years from the start of treatment			No