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

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

October 4, 2000
November 5, 2013
June 2000
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Complete list of historical versions of study NCT00006383 on Archive Site
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Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
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.


  • 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.

Phase 2
Primary Purpose: Treatment
Drug: liposomal vincristine sulfate
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Rodriguez MA, Pytlik R, Kozak T, Chhanabhai M, Gascoyne R, Lu B, Deitcher SR, Winter JN; Marqibo Investigators. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer. 2009 Aug 1;115(15):3475-82. doi: 10.1002/cncr.24359.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2009
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  • 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



  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified


  • 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)


  • 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


  • Not specified


  • 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


  • 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


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


  • 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


  • 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


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


  • 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)
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
CDR0000068259, INEX-CA99002, UCLA-0002028
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Inex Pharmaceuticals
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Study Chair: Barbara Gallimore, PhD Inex Pharmaceuticals
National Cancer Institute (NCI)
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP