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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00364676
First received: August 14, 2006
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Tumors
Hodgkins Disease
Non-Hodgkins Lymphoma
Drug: VLI
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of VLI. [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: July 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00364676     History of Changes
Other Study ID Numbers: HBS501
Study First Received: August 14, 2006
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 19, 2014