CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Recurrent Mantle Cell Lymphoma

In brief

This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, 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 CCI-779 together with rituximab may kill more cancer cells

Key facts

Study ID

NCT00109967

Run by

National Cancer Institute (NCI)

People needed

71

Starts

2005-05-01

Expected to finish

2012-03-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed* mantle cell lymphoma (MCL)
• Relapsed, refractory, or stable disease after prior treatment
• Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by fluorescent in situ hybridization or cytogenetics
• Measurable disease, defined as ≥ 1 of the following:
• Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI
• Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin
• Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes confirmed to be monoclonal by flow cytometry
• No known central nervous system involvement (e.g., parenchymal mass or leptomeningeal involvement)
• Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
• At least 3 months
• No other concurrent treatment for MCL
• Absolute neutrophil count ≥ 1,000/mm\^3
• Platelet count ≥ 75,000/mm\^3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Direct bilirubin < 1.5 times ULN
• Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)
• Creatinine ≤ 2 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Cholesterol ≤ 350 mg/dL
• Fasting triglycerides < 400 mg/dL

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Saint Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Eureka Hospital — Eureka, Illinois, United States
• Galesburg Clinic — Galesburg, Illinois, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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