Status:
COMPLETED
CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab. II. Determine the tolerability of this reg...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- No known HIV positivity
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other active malignancy requiring treatment OR that would preclude assessment of response to study drugs
- Prior biologic response modifiers allowed
- Prior immunotherapy allowed
- Prior high-dose therapy with stem cell support (i.e., stem cell transplantation) allowed
- No concurrent prophylactic growth factor to support neutrophils
- Prior chemotherapy allowed
- No other concurrent chemotherapy
- No concurrent corticosteroids to induce an antitumor response
- Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for adrenal insufficiency or acute allergic reactions allowed
- Prior radiotherapy allowed
- No prior treatment with a mammalian target of rapamycin (mTOR) inhibitor
- No other concurrent investigational or commercial agents or therapies for MCL
- No other concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00109967
Start Date
May 1 2005
End Date
March 1 2012
Last Update
April 17 2014
Active Locations (195)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
2
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301
4
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907