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

Lymphoma Clinical Trial

Official title:

A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00881387
• Other study ID #: 20080919
• Secondary ID: SCCC-2007092
• Status: Withdrawn
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: December 14, 2016
• Start date: February 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• rituximab
Given IV

Drug:
• gemcitabine hydrochloride
Given IV
• vinorelbine ditartrate
Given IV

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete response, unconfirmed complete response, partial response)		After first 3 cycles of treatment	No
Secondary	Progression-free survival, failure-free survival, and overall survival		Treatment start date to date of death for any reason	No
Secondary	Safety profile		Cycle 1 Day 1 through Follow-up	Yes
Secondary	Rate of adequate stem cell collection	This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy	After completion of 3 cycle of treatment	No