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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 ClinicRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
North Suburban Medical CenterThornton, Colorado  80229
Fairview Ridges HospitalBurnsville, Minnesota  55337
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Welch Cancer CenterSheridan, Wyoming  82801
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Community Cancer Center of MonroeMonroe, Michigan  48162
Bismarck Cancer CenterBismarck, North Dakota  58501
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Grandview HospitalDayton, Ohio  45405
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Saint Luke's HospitalMaumee, Ohio  43537
Geisinger Medical GroupState College, Pennsylvania  16801
Miami Valley HospitalDayton, Ohio  45409
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
Longmont United HospitalLongmont, Colorado  80501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Greene Memorial HospitalXenia, Ohio  45385
Rutherford HospitalRutherfordton, North Carolina  28139
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Toledo ClinicOregon, Ohio  43616
Mid Dakota ClinicBismarck, North Dakota  58501
Presbyterian - Saint Lukes Medical Center - Health OneDenver, Colorado  80218
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Oncology AssociatesCedar Rapids, Iowa  52403
Montana Cancer SpecialistsMissoula, Montana  59807-7877
OSF Saint Francis Medical CenterPeoria, Illinois  61637
The Medical Center of AuroraAurora, Colorado  80012
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Saint Anthony Central HospitalDenver, Colorado  80204
Exempla Saint Joseph HospitalDenver, Colorado  80218
Colorado Cancer Research Program CCOPDenver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado  81502
Saint Mary Corwin Medical CenterPueblo, Colorado  81004
Rush - Copley Medical CenterAurora, Illinois  60504
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Foundation dba Carle Cancer CenterUrbana, Illinois  61801
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
McFarland ClinicAmes, Iowa  50010
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Saint Luke's HospitalCedar Rapids, Iowa  52402
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center - North IowaMason City, Iowa  50401
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Merit Care Clinic BemidjiBemidji, Minnesota  56601
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Duluth Clinic CCOPDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Saint Alexius Medical CenterBismarck, North Dakota  58501
Medcenter One Health SystemsBismarck, North Dakota  58501
Meritcare HospitalFargo, North Dakota  58122
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Veteran Affairs Medical CenterDayton, Ohio  45428
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Cole, Sharon, K. M.D. (UIA Investigator)Kenton, Ohio  43326
Kettering Medical CenterKettering, Ohio  45429
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Bayview Oncology AssociatesOregon, Ohio  43616
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Flower Memorial HospitalSylvania, Ohio  43560
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Upper Valley Medical CenterTroy, Ohio  45373
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
AnMed Health HospitalAnderson, South Carolina  29621
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Stark, Michael, Edward. M.D. (UIA Investigator)Toledo, Ohio  43623