Study of NS-9 in Patients With Liver Metastases

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094003
• Other study ID #: NS9001
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2004
• Last updated: November 9, 2005
• Start date: September 2002

Study information

• Verified date: November 2005
• Source: NS Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Local Neoplasm Recurrences
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Neoplasms
• Recurrence

Intervention

Drug:
• NS-9 [Poly I: Poly C]

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
NS Pharma, Inc.

Country where clinical trial is conducted

United States,