Overview

This trial is active, not recruiting.

Condition sarcoma
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date August 1998
Trial size 40 participants
Trial identifier NCT00003515, BC-PN-2, CDR0000066558

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 studies the effectiveness of antineoplaston therapy in treating patients who have metastatic, recurrent, or refractory primitive neuroectodermal tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants of any age.

DISEASE CHARACTERISTICS: - Histologically confirmed incurable primitive neuroectodermal tumors outside the central nervous system that are unlikely to respond to existing therapy, meeting 1 of the following criteria: - Metastatic disease - Progressive, recurrent, or refractory disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy - Measurable disease by MRI or CT scan - Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: - 6 months and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - No renal insufficiency - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No active infection - No nonmalignant systemic disease - Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed - No prior antineoplastons - No other concurrent antineoplastic agents

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System
Description OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable primitive neuroectodermal tumors outside the central nervous system. - Describe 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 antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).