Study of NS-9 in Patients With Liver Metastases
- Conditions
- Liver NeoplasmsNeoplasm MetastasisLocal Neoplasm Recurrences
- Registration Number
- NCT00094003
- Lead Sponsor
- NS Pharma, Inc.
- Brief 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.
- Detailed Description
This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.
After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States