Study of NS-9 in Patients With Liver Metastases

A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers

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.

Study Overview

• Status: Completed
• Conditions: Neoplasm Metastasis; Liver Neoplasms; Local Neoplasm Recurrences
• Intervention / Treatment: Drug: NS-9 [Poly I: Poly C]

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.

• Study Type: Interventional
• Enrollment: 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: NS Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2002

Study Registration Dates

• First Submitted: October 8, 2004
• First Submitted That Met QC Criteria: October 8, 2004
• First Posted (Estimate): October 11, 2004

Study Record Updates

• Last Update Posted (Estimate): November 11, 2005
• Last Update Submitted That Met QC Criteria: November 9, 2005
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Keywords: Colorectal cancer; Gastric cancer; Breast cancer; Lung cancer; Skin cancer; Renal Cancer; Liver metastases; Liver metastasis; Esophagus cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Recurrence; Liver Neoplasms; Neoplasms, Second Primary; Neoplasm Recurrence, Local; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Immunologic Factors; Interferon Inducers; Poly I-C
• Other Study ID Numbers: NS9001