Overview

This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date September 1995
End date December 2011
Trial size 40 participants
Trial identifier NCT00003460, BC-BT-12, CDR0000066492

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 primitive neuroectodermal tumors that has not responded to standard therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate assessed by tumor measurements at 12 weeks
time frame:

Secondary Outcomes

Measure
Survival at 1, 2, and 5 years after start of treatment
time frame:

Eligibility Criteria

Male or female participants up to 17 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed (except if medically contraindicated) incurable primitive neuroectodermal tumor - Evidence of progressive or recurrent tumor by MRI or CT scan performed within 2 weeks prior to study entry - Must have received and failed prior standard therapy - Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: - 6 months to 17 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal - No hepatic insufficiency Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No severe heart disease - 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 participation - No serious active infections or fever - No other serious concomitant 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: - Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry) Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston treatment

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors
Description OBJECTIVES: - Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with primitive neuroectodermal 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 patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times a day until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).