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Study of NS-9 in Patients With Liver Metastases

Primary Purpose

Liver Neoplasms, Neoplasm Metastasis, Local Neoplasm Recurrences

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NS-9 [Poly I: Poly C]
Sponsored by
NS Pharma, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Liver metastases, Colorectal cancer, Gastric cancer, Esophagus cancer, Breast cancer, Lung cancer, Skin cancer, Renal Cancer, Liver metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dartmouth-Hitchcock Medical Center
  • MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2004
Last Updated
November 9, 2005
Sponsor
NS Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00094003
Brief Title
Study of NS-9 in Patients With Liver Metastases
Official Title
A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NS Pharma, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms, Neoplasm Metastasis, Local Neoplasm Recurrences
Keywords
Liver metastases, Colorectal cancer, Gastric cancer, Esophagus cancer, Breast cancer, Lung cancer, Skin cancer, Renal Cancer, Liver metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NS-9 [Poly I: Poly C]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study of NS-9 in Patients With Liver Metastases

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