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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006383
First received: October 4, 2000
Last updated: November 5, 2013
Last verified: December 2002
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: liposomal vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Study Completion Date: August 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00006383

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006383     History of Changes
Other Study ID Numbers: CDR0000068259, INEX-CA99002, UCLA-0002028
Study First Received: October 4, 2000
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Vincristine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014