Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date August 1998
Trial size 40 participants
Trial identifier NCT00003524, BC-ST-2, CDR0000066568

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 stomach cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma of the stomach that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan PATIENT CHARACTERISTICS: Age: - 18 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 known chronic heart failure - 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 - Not a high medical or psychiatric risk - No concurrent nonmalignant systemic disease - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed - No other concurrent antineoplastic agents

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Stomach
Description OBJECTIVES: - Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of the stomach. - 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 antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 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: 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 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).