NCT00094003

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2004

Completed
Last Updated

November 11, 2005

Status Verified

November 1, 2005

First QC Date

October 8, 2004

Last Update Submit

November 9, 2005

Conditions

Liver NeoplasmsNeoplasm MetastasisLocal Neoplasm Recurrences

Keywords

Liver metastasesColorectal cancerGastric cancerEsophagus cancerBreast cancerLung cancerSkin cancerRenal CancerLiver metastasis

Interventions

NS-9 [Poly I: Poly C]DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm MetastasisNeoplasm Recurrence, LocalColorectal NeoplasmsStomach NeoplasmsEsophageal NeoplasmsBreast NeoplasmsLung NeoplasmsSkin NeoplasmsKidney Neoplasms

Interventions

Poly I-C

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Poly CPolyribonucleotidesPolynucleotidesNucleotidesNucleic Acids, Nucleotides, and NucleosidesPoly I

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2004

First Posted

October 11, 2004

Study Start

September 1, 2002

Last Updated

November 11, 2005

Record last verified: 2005-11

Locations

US(2)