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

Primary Purpose

Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VLI
VLI
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumors focused on measuring Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors

Eligibility Criteria

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

Inclusion Criteria: 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 Adequate hematologic, hepatic and renal functions as defined by laboratory tests. At least 18 years of age. Have a life expectancy of at least 12 weeks. Patients must give written informed consent. ECOG or Zubrod performance status of 0, 1, or 2. Exclusion Criteria: 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. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C). Planned concurrent systemic therapy and/or radiotherapy drug study treatment. Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa). Female patients who are pregnant or lactating. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

Sites / Locations

  • Cancer Therapy and Research Center
  • South Texas Accelerated Research Therapeutics
  • McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Patients are dosed on Day 1 and Day 8 of a 21-day cycle.

Patients are dosed on Day 1 of a 21-day cycle.

Outcomes

Primary Outcome Measures

Evaluate the safety and tolerability of VLI.

Secondary Outcome Measures

To determine the maximum tolerated dose (MTD)

Full Information

First Posted
August 14, 2006
Last Updated
September 18, 2015
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00364676
Brief Title
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma
Keywords
Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Arm Title
2
Arm Type
Experimental
Arm Description
Patients are dosed on Day 1 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
VLI
Intervention Description
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
VLI
Intervention Description
Patients are dosed on Day 1 of a 21-day cycle.
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of VLI.
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD)
Time Frame
21 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Adequate hematologic, hepatic and renal functions as defined by laboratory tests. At least 18 years of age. Have a life expectancy of at least 12 weeks. Patients must give written informed consent. ECOG or Zubrod performance status of 0, 1, or 2. Exclusion Criteria: 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. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C). Planned concurrent systemic therapy and/or radiotherapy drug study treatment. Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa). Female patients who are pregnant or lactating. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sarantopoulos, MD
Organizational Affiliation
Cancer Therapy and Research Center, Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald Batist, MD
Organizational Affiliation
McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony W. Tolcher, MD
Organizational Affiliation
South Texas Accelerated Research Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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