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

September 18, 2015 updated by: Spectrum Pharmaceuticals, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Drug: VLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Drug: VLI
Patients are dosed on Day 1 of a 21-day cycle.
EXPERIMENTAL: 2
Patients are dosed on Day 1 of a 21-day cycle.
Drug: VLI
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
Drug: VLI
Patients are dosed on Day 1 of a 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety and tolerability of VLI.
Time Frame: 21 Days
21 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose (MTD)
Time Frame: 21 Days
21 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Investigators

  • Principal Investigator: John Sarantopoulos, MD, Cancer Therapy and Research Center, Texas
  • Principal Investigator: Gerald Batist, MD, McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
  • Principal Investigator: Anthony W. Tolcher, MD, South Texas Accelerated Research Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (ESTIMATE)

August 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBS501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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