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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00003477
Other study ID # CDR0000066514
Secondary ID BC-BT-23
Status Recruiting
Phase Phase 2
First received November 1, 1999
Last updated June 9, 2009
Start date June 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 visual pathway glioma.


Description:

OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with visual pathway glioma by determining the proportion of patients who experience an objective tumor response.

- Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open label study.

Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.


Recruitment information / eligibility

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

- Histologically confirmed (unless medically contraindicated) visual pathway glioma that is unlikely to respond to existing therapy and for which no curative therapy exists

- Evidence of tumor by MRI or CT scan

- Tumor must be at least 5 mm

- No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count greater than 50,000/mm3

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 renal insufficiency

- 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 other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe lung disease

Other:

- Not pregnant or nursing

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

- 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 and recovered (6 weeks for nitrosoureas)

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No prior antineoplaston therapy

Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


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 taken at 12 weeks No
Secondary Survival at 1, 2, and 5 years from the start of treatment No
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