Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 cancer-killing substances to them. Giving clofarabine together with rituximab may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with rituximab and to see how well they work in treating patients with relapsed B-cell non-Hodgkin lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Clofarabine; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed B-cell lymphoma

• Relapsed disease

• CD20-positive disease

• Must have had bone marrow aspiration and biopsy (uni- or bilateral) within the past 42 days and chest CT and CT of the abdomen and pelvis within the past 28 days

• Documented bidimensionally measurable disease within the past 28 days

• Patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group(ECOG) performance status 0-2

• Leukocyte count ≥ 3,000/μL

• Absolute neutrophil count ≥ 1,500/μL

• Platelet count ≥ 75,000/μL

• Total bilirubin ≤ 2 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy

• No known AIDS or HIV-associated complex

• No active hepatitis B infection

• No other severe concurrent disease, history of serious organ dysfunction, or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment

• No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment

• No history of intolerance or allergic reactions to clofarabine or rituximab

• No significant concurrent disease, illness, or psychiatric disorder that would compromise the patient's safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

• No concurrent active GI disease that may impair absorption of oral clofarabine

PRIOR CONCURRENT THERAPY:

• Recovered from all previous therapies

• No prior gastrointestinal (GI) surgery that may impair absorption of oral clofarabine

• More than 2 weeks since prior and no concurrent anticancer therapy, except for hydroxyurea

• More than 4 weeks since prior radioimmunotherapy

• More than 1 month since prior investigational agents

• No concurrent cytotoxic therapy or investigational therapy

• No other concurrent investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy

• No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)

• No other concurrent chemotherapy or immunotherapy

• No concurrent radiotherapy

• No concurrent colony stimulating factors (phase I portion of the study)