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

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ClinicalTrials.gov Identifier: NCT00364676
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tumors Hodgkins Disease Non-Hodgkins Lymphoma Drug: VLI Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Primary Completion Date : June 2015
Study Completion Date : August 2015


Arms and Interventions

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.
Experimental: 2
Patients are dosed on Day 1 of a 21-day cycle.
Drug: VLI
Patients are dosed on Day 1 of a 21-day cycle.


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the safety and tolerability of VLI. [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) [ Time Frame: 21 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364676


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

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00364676     History of Changes
Other Study ID Numbers: HBS501
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Spectrum Pharmaceuticals, Inc:
Vinorelbine
solid tumors
Hodgkins
Non hodgkins
Lymphoma
Advanced solid tumors

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents