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

About this trial
This is an interventional treatment trial for Recurrent Mantle Cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- Mobile Infirmary Medical Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Saint Anthony Central Hospital
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Eureka Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Mcdonough District Hospital
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- Saint Margaret's Hospital
- Carle Clinic-Urbana Main
- Carle Foundation dba Carle Cancer Center
- Saint Francis Hospital and Health Centers
- Saint Anthony Memorial Health Center
- Reid Hospital and Health Care Services
- McFarland Clinic
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Siouxland Hematology - Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Oakwood Hospital
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Merit Care Clinic Bemidji
- Fairview Ridges Hospital
- Mercy Hospital
- Duluth Clinic CCOP
- Miller-Dwan Hospital
- Saint Mary's Medical Center
- Fairview-Southdale Hospital
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Abbott-Northwestern Hospital
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Minnesota Oncology and Hematology PA-Woodbury
- Hematology-Oncology Centers of the Northern Rockies PC
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Billings Clinic
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Health Systems
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Meritcare Hospital
- MeritCare Medical Group
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Veteran Affairs Medical Center
- Dayton CCOP
- Hematology Oncology Center Incorporated
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Fremont Memorial Hospital
- Wayne Hospital
- Cole, Sharon, K. M.D. (UIA Investigator)
- Kettering Medical Center
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- Saint Luke's Hospital
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Bayview Oncology Associates
- Saint Charles Hospital
- Firelands Regional Medical Center
- North Coast Cancer Care
- Flower Memorial Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Cancer Center at Saint Anne Mercy Hospital
- Stark, Michael, Edward. M.D. (UIA Investigator)
- Toledo Clinic
- Upper Valley Medical Center
- Fulton County Health Center
- Clinton Memorial Hospital
- Greene Memorial Hospital
- Lehigh Valley Hospital
- Geisinger Medical Center
- Geisinger Medical Group
- Geisinger Wyoming Valley
- AnMed Health Hospital
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Fredericksburg Oncology Inc
- Welch Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.