Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

November 5, 2013 updated by: Inex Pharmaceuticals

Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the complete and partial tumor responses in patients with aggressive non-Hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection.
  • Determine the toxicity of this treatment regimen in these patients.
  • Determine the duration of response, time to progression, and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.

Study Type

Interventional

Phase

  • Phase 2

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
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Texas
      • Tyler, Texas, United States, 75708
        • University of Texas Health Center at Tyler
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma including:

    • Peripheral T-cell lymphoma not otherwise specified
    • Anaplastic large null-/T-cell lymphoma

    • Diffuse large B-cell lymphoma including:

      • Primary mediastinal large B-cell lymphoma with sclerosis
      • Intravascular large B-cell lymphoma
      • Immunoblastic B-cell lymphoma
      • T-cell-rich B-cell lymphoma
      • Anaplastic large B-cell lymphoma
  • At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan
  • No prior or active CNS lymphoma or AIDS-related lymphoma

  • Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive

    • Prior first and second-line therapy must have been combination chemotherapy
    • Prior first-line chemotherapy regimen must have contained anthracycline
    • Must have had at least a minor response to first-line therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 500/mm^3 (unless due to lymphoma bone marrow involvement)
  • Platelet count at least 50,000/mm^3 (unless due to lymphoma bone marrow involvement)

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • ALT no greater than 4 times ULN
  • Alkaline phosphatase no greater than 4 times ULN

Renal:

  • Not specified

Neurologic:

  • No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders)
  • No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar)
  • No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy

Other:

  • No uncontrolled severe medical illness or infection
  • HIV negative
  • No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Radiotherapy
  • No prior allogeneic bone marrow or peripheral blood stem cell transplantation
  • At least 4 weeks since prior immunotherapy
  • No concurrent biological agents

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent

Radiotherapy:

  • Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease
  • Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy to any disease site

Surgery:

  • At least 4 weeks since prior major surgery except for diagnosis of lymphoma
  • No concurrent surgical removal of any indicator lesion

Other:

  • At least 4 weeks since prior alternative or investigational anticancer treatment
  • No other concurrent systemic anticancer therapy
  • No other concurrent investigational drug
  • No concurrent phenytoin
  • No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)

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

Collaborators and Investigators

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

Sponsor

Inex Pharmaceuticals

Investigators

  • Study Chair: Barbara Gallimore, PhD, Inex Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2000

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

May 29, 2003

First Posted (ESTIMATE)

May 30, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068259
  • INEX-CA99002
  • UCLA-0002028

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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