Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
NCT ID: NCT00881387
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2009-02-28
2012-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
rituximab
Given IV
gemcitabine hydrochloride
Given IV
vinorelbine ditartrate
Given IV
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.
rituximab
Given IV
gemcitabine hydrochloride
Given IV
vinorelbine ditartrate
Given IV
Interventions
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rituximab
Given IV
gemcitabine hydrochloride
Given IV
vinorelbine ditartrate
Given IV
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Principal Investigators
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Alexandra Stefanovic, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Countries
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Other Identifiers
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SCCC-2007092
Identifier Type: -
Identifier Source: secondary_id
20080919
Identifier Type: -
Identifier Source: org_study_id