CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Recurrent Mantle Cell Lymphoma

In brief

Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Key facts

Study ID

NCT00033267

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2002-04-01

Expected to finish

2008-02-01

Last updated by the study team

2014-04-03

Who can join

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

You may qualify if…

• Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
• Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
• Unidimensionally measurable lymph node or lesion
• At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
• One of the following measurement parameters may be used:
• Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
• Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm\^3
• No known CNS involvement (parenchymal mass or leptomeningeal involvement)
• Performance status - ECOG 0-2
• At least 3 months
• See Disease Characteristics
• Absolute neutrophil count ≥ 1,000/mm\^3
• Platelet count ≥ 75,000/mm\^3
• Hemoglobin ≥ 8 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Direct bilirubin ≤ 1.5 times ULN
• AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
• Creatinine ≤ 2 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Cholesterol ≤ 350 mg/dL
• Triglycerides ≤ 400 mg/dL
• HIV negative
• No other active malignancy requiring treatment or that would preclude study participation

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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