Study of NS-9 in Patients With Liver Metastases

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NS Pharma, Inc.
• Treatments: Poly I-C

Criteria

Inclusion Criteria:

• Male and female at least 18 years of age.

• Patients with liver metastases from various primary cancers for which no other curative treatment options exist.

• At least one measurable lesion (by CT or MRI)

• Life expectancy > 3 months

• Child-bearing potential women must have a negative serum pregnancy test

• ECOG performance status: 0-1

• Fully recovered from any previous cancer therapy or infection (at least 4 weeks from radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at least 2 weeks from an exploration/biopsy)

• Discontinued from any other investigational drug for at least 30 days

• Serum calcium <11 mg/dL

• Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support

• Hemoglobin ≥9.0 g/dL

• Platelet count ≥100,000/mm3

• Serum creatinine ≤1.5 times the upper limit of normal (ULN)

• Bilirubin ≤1.5 times ULN

• ALT and AST ≤3 times ULN

• Amylase and lipase ≤ ULN

• PT and PTT < 1.5 times ULN

• ECG with no acute abnormalities

• Afebrile (≤37.5C or 99.5F)

• Willingness and ability to comply with all study requirements

Exclusion Criteria:

• Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.

• Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).

• History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).

• New York Heart Association classification Class III or IV

• Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.

• Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.

• Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.

• Subject has received radiation to >25% of the total bone marrow.

• Subject has a history of any other illness that would preclude study participation.

• Subject has brain metastases.

• Subject has allergy to egg yolk.

• Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).