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

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Gemcitabine; Rituximab; Vinblastine; Vinorelbine

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