Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Tumors Clinical Trial

Official title:

A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364676
• Other study ID #: HBS501
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2006
• Last updated: September 18, 2015
• Start date: July 2006
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

Description:

The objectives of this study are:

• To assess the safety and tolerability of treatment with VLI.

• To determine the maximum tolerated dose (MTD) of VLI.

• To characterize the pharmacokinetic (PK) profile of VLI.

• To explore preliminary tumor response of VLI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease

2. Adequate hematologic, hepatic and renal functions as defined by laboratory tests.

3. At least 18 years of age.

4. Have a life expectancy of at least 12 weeks.

5. Patients must give written informed consent.

6. ECOG or Zubrod performance status of 0, 1, or 2.

Exclusion Criteria:

1. Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.

2. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).

3. Planned concurrent systemic therapy and/or radiotherapy drug study treatment.

4. Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.

5. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.

6. Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).

7. Female patients who are pregnant or lactating.

8. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkins Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma
• Tumors

Intervention

Drug:
• VLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
• VLI
Patients are dosed on Day 1 of a 21-day cycle.

Locations

Country	Name	City	State
Canada	McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit	Montreal	Quebec
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of VLI.		21 Days	Yes
Secondary	To determine the maximum tolerated dose (MTD)		21 Days	No