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This study has been withdrawn prior to enrollment.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: July 25, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: gemcitabine hydrochloride
Drug: vinorelbine ditartrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response rate (complete response, unconfirmed complete response, partial response) [ Time Frame: After first 3 cycles of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: rituximab
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: vinorelbine ditartrate
Given IV
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.
Biological: rituximab
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: vinorelbine ditartrate
Given IV

Detailed Description:

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.

  Eligibility

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

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
  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: NCT00881387

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Alexandra Stefanovic, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00881387     History of Changes
Other Study ID Numbers: UMIAMI-20080919, SCCC-2007092
Study First Received: April 14, 2009
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
recurrent adult Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Vinorelbine
Rituximab
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014