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A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Mantle Cell Lymphoma

Thank you

Trial Information

A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma


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 regimen in these patients. III. Determine adverse
events in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. Determine the time to disease progression and overall survival of patients treated with
this regimen.

II. Determine the time to response and duration of response in patients treated with this
regimen.

OUTLINE: Patients are stratified according to prior response to rituximab (sensitive
[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last
treatment with rituximab alone or in combination with chemotherapy] vs refractory [stable or
progressive disease OR a PR or CR that lasted < 6 months after the last treatment with
rituximab alone or in combination with chemotherapy]).

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.

After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.


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 CNS involvement (e.g., parenchymal mass or leptomeningeal involvement)

- Performance status - 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

- 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 mTOR inhibitor

- No other concurrent investigational or commercial agents or therapies for MCL

- No other concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete, partial, and unconfirmed) during the first 24 weeks of treatment as defined by the International Workshop criteria

Outcome Time Frame:

Not Provided

Safety Issue:

No

Principal Investigator

Stephen Ansell

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00644

NCT ID:

NCT00109967

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

Mayo Clinic Rochester, Minnesota  55905
Hurley Medical Center Flint, Michigan  48503
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Fairview Ridges Hospital Burnsville, Minnesota  55337
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Avera Cancer Institute Sioux Falls, South Dakota  57105
Methodist Medical Center of Illinois Peoria, Illinois  61636
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Great Falls Clinic Great Falls, Montana  59405
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Avera McKennan Hospital and University Health Center Sioux Falls, South Dakota  57105
Welch Cancer Center Sheridan, Wyoming  82801
Memorial Hospital Carthage, Illinois  62321
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Community Cancer Center of Monroe Monroe, Michigan  48162
Bismarck Cancer Center Bismarck, North Dakota  58501
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Grandview Hospital Dayton, Ohio  45405
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
Northwest Ohio Oncology Center Maumee, Ohio  43537
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Pekin Hospital Pekin, Illinois  61554
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Saint Luke's Hospital Maumee, Ohio  43537
Geisinger Medical Group State College, Pennsylvania  16801
Miami Valley Hospital Dayton, Ohio  45409
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Hospital District Sixth of Harper County Anthony, Kansas  67003
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
Longmont United Hospital Longmont, Colorado  80501
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Greene Memorial Hospital Xenia, Ohio  45385
Rutherford Hospital Rutherfordton, North Carolina  28139
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Toledo Clinic Oregon, Ohio  43616
Mid Dakota Clinic Bismarck, North Dakota  58501
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Oncology Associates Cedar Rapids, Iowa  52403
Montana Cancer Specialists Missoula, Montana  59807-7877
OSF Saint Francis Medical Center Peoria, Illinois  61637
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Rush - Copley Medical Center Aurora, Illinois  60504
Hopedale Medical Complex - Hospital Hopedale, Illinois  61747
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Saint Margaret's Hospital Spring Valley, Illinois  61362
Carle Foundation dba Carle Cancer Center Urbana, Illinois  61801
Carle Clinic-Urbana Main Urbana, Illinois  61801
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Saint Anthony Memorial Health Center Michigan City, Indiana  46360
Reid Hospital and Health Care Services Richmond, Indiana  47374
McFarland Clinic Ames, Iowa  50010
Cedar Rapids Oncology Association Cedar Rapids, Iowa  52403
Mercy Hospital Cedar Rapids, Iowa  52403
Saint Luke's Hospital Cedar Rapids, Iowa  52402
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center - North Iowa Mason City, Iowa  50401
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Siouxland Hematology - Oncology Associates Sioux City, Iowa  51101
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Hickman Cancer Center Adrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital Monroe, Michigan  48162
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Merit Care Clinic Bemidji Bemidji, Minnesota  56601
Saint Mary's Medical Center Duluth, Minnesota  55805
Miller-Dwan Hospital Duluth, Minnesota  55805
Duluth Clinic CCOP Duluth, Minnesota  55805
Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Deaconess Medical Center Billings, Montana  59107
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Saint Alexius Medical Center Bismarck, North Dakota  58501
Medcenter One Health Systems Bismarck, North Dakota  58501
Meritcare Hospital Fargo, North Dakota  58122
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Veteran Affairs Medical Center Dayton, Ohio  45428
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Cole, Sharon, K. M.D. (UIA Investigator) Kenton, Ohio  43326
Kettering Medical Center Kettering, Ohio  45429
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee, Ohio  43537
Bayview Oncology Associates Oregon, Ohio  43616
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Flower Memorial Hospital Sylvania, Ohio  43560
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
The Toledo Hospital Toledo, Ohio  43606
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Upper Valley Medical Center Troy, Ohio  45373
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
AnMed Health Hospital Anderson, South Carolina  29621
Upstate Carolina CCOP Spartanburg, South Carolina  29303
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Stark, Michael, Edward. M.D. (UIA Investigator) Toledo, Ohio  43623