Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00881387
First received: April 14, 2009
Last updated: August 13, 2013
Last verified: August 2013

April 14, 2009
August 13, 2013
February 2009
October 2012   (final data collection date for primary outcome measure)
Response rate (complete response, unconfirmed complete response, partial response) [ Time Frame: After first 3 cycles of treatment ] [ Designated as safety issue: No ]
Response rate (complete response, unconfirmed complete response, partial response) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00881387 on ClinicalTrials.gov Archive Site
  • Progression-free survival, failure-free survival, and overall survival [ Time Frame: Treatment start date to date of death for any reason ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: Cycle 1 Day 1 through Follow-up ] [ Designated as safety issue: Yes ]
  • Rate of adequate stem cell collection [ Time Frame: After completion of 3 cycle of treatment ] [ Designated as safety issue: No ]
    This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy
  • Progression-free survival, failure-free survival, and overall survival [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: Yes ]
  • Rate of adequate stem cell collection [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.

OBJECTIVES:

Primary

  • Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate.

Secondary

  • Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen.
  • Characterize the safety profile of this regimen in these patients.
  • Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).

  • Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
  • Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed for at least 2 years.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: rituximab
    Given IV
  • Drug: gemcitabine hydrochloride
    Given IV
  • Drug: vinorelbine ditartrate
    Given IV
  • Experimental: Group 1 (eligible for SCT)
    Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
    Interventions:
    • Biological: rituximab
    • Drug: gemcitabine hydrochloride
    • Drug: vinorelbine ditartrate
  • Experimental: Group 2 (ineligible for SCT)
    Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Biological: rituximab
    • Drug: gemcitabine hydrochloride
    • Drug: vinorelbine ditartrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2012
October 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:

    • Nodular sclerosis
    • Mixed cellularity
    • Lymphocyte-rich
    • Lymphocyte-depleted
  • Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
  • Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
  • No known CNS metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC > 1,500/mm^3
  • Platelet count > 75,000/mm^3
  • Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
  • AST or ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active hepatitis B infection
  • No known chronic hepatitis B carrier
  • No HIV positivity
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Symptomatic neurological illness
    • Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Significant pulmonary disease or hypoxia
    • Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered
  • No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab
  • No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00881387
UMIAMI-20080919, SCCC-2007092
Yes
University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
Not Provided
Study Chair: Alexandra Stefanovic, MD University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
August 2013

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