Overview

This trial is active, not recruiting.

Condition carcinoma of unknown primary
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date March 1996
End date February 2008
Trial size 40 participants
Trial identifier NCT00003526, BC-UP-2, CDR0000066570

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 patients with cancer of unknown primary origin.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate based on tumor measurements at 12 weeks
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of unknown primary 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: - 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 severe 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: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy Surgery: - 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 Adenocarcinoma of Unknown Primary
Description OBJECTIVES: - Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of unknown primary. - 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 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: Approximately 20-40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).