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

21 maart 2014 bijgewerkt door: National Cancer Institute (NCI)

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

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, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 by assessing toxicity.

SECONDARY OBJECTIVES:

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

II. Determine the 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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

71

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Mobile, Alabama, Verenigde Staten, 36607
        • Mobile Infirmary Medical Center
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Verenigde Staten, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Verenigde Staten, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, Verenigde Staten, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Verenigde Staten, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Verenigde Staten, 80220
        • Rose Medical Center
      • Denver, Colorado, Verenigde Staten, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, Verenigde Staten, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Denver, Colorado, Verenigde Staten, 80204
        • Saint Anthony Central Hospital
      • Englewood, Colorado, Verenigde Staten, 80110
        • Swedish Medical Center
      • Grand Junction, Colorado, Verenigde Staten, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, Verenigde Staten, 80631
        • North Colorado Medical Center
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Verenigde Staten, 80501
        • Longmont United Hospital
      • Loveland, Colorado, Verenigde Staten, 80539
        • McKee Medical Center
      • Pueblo, Colorado, Verenigde Staten, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, Verenigde Staten, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, Verenigde Staten, 80033
        • Exempla Lutheran Medical Center
    • Illinois
      • Aurora, Illinois, Verenigde Staten, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, Verenigde Staten, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, Verenigde Staten, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Verenigde Staten, 62321
        • Memorial Hospital
      • Eureka, Illinois, Verenigde Staten, 61530
        • Eureka Hospital
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Galesburg Clinic
      • Havana, Illinois, Verenigde Staten, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Verenigde Staten, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, Verenigde Staten, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Kewanee, Illinois, Verenigde Staten, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Verenigde Staten, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Verenigde Staten, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Verenigde Staten, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Verenigde Staten, 61554
        • Pekin Cancer Treatment Center
      • Pekin, Illinois, Verenigde Staten, 61554
        • Pekin Hospital
      • Peoria, Illinois, Verenigde Staten, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Verenigde Staten, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Verenigde Staten, 61614
        • Proctor Hospital
      • Peoria, Illinois, Verenigde Staten, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Verenigde Staten, 61615
        • Illinois Oncology Research Association CCOP
      • Peru, Illinois, Verenigde Staten, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Verenigde Staten, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Verenigde Staten, 61362
        • Saint Margaret's Hospital
      • Urbana, Illinois, Verenigde Staten, 61801
        • Carle Clinic-Urbana Main
      • Urbana, Illinois, Verenigde Staten, 61801
        • Carle Foundation dba Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Verenigde Staten, 46107
        • Saint Francis Hospital and Health Centers
      • Michigan City, Indiana, Verenigde Staten, 46360
        • Saint Anthony Memorial Health Center
      • Richmond, Indiana, Verenigde Staten, 47374
        • Reid Hospital and Health Care Services
    • Iowa
      • Ames, Iowa, Verenigde Staten, 50010
        • McFarland Clinic
      • Cedar Rapids, Iowa, Verenigde Staten, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Verenigde Staten, 52402
        • Saint Luke's Hospital
      • Cedar Rapids, Iowa, Verenigde Staten, 52403
        • Cedar Rapids Oncology Association
      • Cedar Rapids, Iowa, Verenigde Staten, 52403
        • Oncology Associates
      • Clive, Iowa, Verenigde Staten, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Verenigde Staten, 50307
        • Mercy Capitol
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Iowa Oncology Research Association CCOP
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Medical Oncology and Hematology Associates
      • Mason City, Iowa, Verenigde Staten, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, Verenigde Staten, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Verenigde Staten, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Verenigde Staten, 51104
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, Verenigde Staten, 51101
        • Siouxland Hematology - Oncology Associates
    • Kansas
      • Anthony, Kansas, Verenigde Staten, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, Verenigde Staten, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Verenigde Staten, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Verenigde Staten, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Verenigde Staten, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Verenigde Staten, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Verenigde Staten, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Verenigde Staten, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, Verenigde Staten, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Verenigde Staten, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Verenigde Staten, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Verenigde Staten, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Verenigde Staten, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Verenigde Staten, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Verenigde Staten, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Verenigde Staten, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, Verenigde Staten, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, Verenigde Staten, 67214
        • Wichita CCOP
      • Winfield, Kansas, Verenigde Staten, 67156
        • Cancer Center of Kansas - Winfield
    • Michigan
      • Adrian, Michigan, Verenigde Staten, 49221
        • Bixby Medical Center
      • Adrian, Michigan, Verenigde Staten, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, Verenigde Staten, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, Verenigde Staten, 48106
        • Michigan Cancer Research Consortium Community Clinical Oncology Program
      • Dearborn, Michigan, Verenigde Staten, 48123
        • Oakwood Hospital
      • Detroit, Michigan, Verenigde Staten, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, Verenigde Staten, 48502
        • Hurley Medical Center
      • Flint, Michigan, Verenigde Staten, 48532
        • Genesys Regional Medical Center
      • Jackson, Michigan, Verenigde Staten, 49201
        • Allegiance Health
      • Lansing, Michigan, Verenigde Staten, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Verenigde Staten, 48154
        • Saint Mary Mercy Hospital
      • Monroe, Michigan, Verenigde Staten, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Verenigde Staten, 48162
        • Community Cancer Center of Monroe
      • Pontiac, Michigan, Verenigde Staten, 48341-2985
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Verenigde Staten, 48060
        • Saint Joseph Mercy Port Huron
      • Saginaw, Michigan, Verenigde Staten, 48601
        • Saint Mary's of Michigan
      • Warren, Michigan, Verenigde Staten, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Bemidji, Minnesota, Verenigde Staten, 56601
        • Merit Care Clinic Bemidji
      • Burnsville, Minnesota, Verenigde Staten, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Verenigde Staten, 55433
        • Mercy Hospital
      • Duluth, Minnesota, Verenigde Staten, 55805
        • Miller-Dwan Hospital
      • Duluth, Minnesota, Verenigde Staten, 55805
        • Saint Mary's Medical Center
      • Duluth, Minnesota, Verenigde Staten, 55805
        • Duluth Clinic CCOP
      • Edina, Minnesota, Verenigde Staten, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Verenigde Staten, 55432
        • Unity Hospital
      • Maplewood, Minnesota, Verenigde Staten, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Verenigde Staten, 55407
        • Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Verenigde Staten, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Metro-Minnesota CCOP
      • Saint Paul, Minnesota, Verenigde Staten, 55102
        • United Hospital
      • Shakopee, Minnesota, Verenigde Staten, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, Verenigde Staten, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Verenigde Staten, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Montana
      • Billings, Montana, Verenigde Staten, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Verenigde Staten, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Verenigde Staten, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, Verenigde Staten, 59107-7000
        • Billings Clinic
      • Billings, Montana, Verenigde Staten, 59107
        • Deaconess Medical Center
      • Billings, Montana, Verenigde Staten, 59101
        • Hematology-Oncology Centers of the Northern Rockies PC
      • Bozeman, Montana, Verenigde Staten, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, Verenigde Staten, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Verenigde Staten, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Verenigde Staten, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Verenigde Staten, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Havre, Montana, Verenigde Staten, 59501
        • Northern Montana Hospital
      • Helena, Montana, Verenigde Staten, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Verenigde Staten, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Verenigde Staten, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, Verenigde Staten, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, Verenigde Staten, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Verenigde Staten, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Verenigde Staten, 59801
        • Community Medical Hospital
      • Missoula, Montana, Verenigde Staten, 59802
        • Montana Cancer Specialists
    • North Carolina
      • Rutherfordton, North Carolina, Verenigde Staten, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Saint Alexius Medical Center
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Medcenter One Health Systems
      • Fargo, North Dakota, Verenigde Staten, 58122
        • MeritCare Medical Group
      • Fargo, North Dakota, Verenigde Staten, 58122
        • Meritcare Hospital
    • Ohio
      • Bowling Green, Ohio, Verenigde Staten, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, Verenigde Staten, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Verenigde Staten, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Verenigde Staten, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, Verenigde Staten, 45405
        • Grandview Hospital
      • Dayton, Ohio, Verenigde Staten, 45428
        • Veteran Affairs Medical Center
      • Dayton, Ohio, Verenigde Staten, 45429
        • Dayton CCOP
      • Elyria, Ohio, Verenigde Staten, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, Verenigde Staten, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, Verenigde Staten, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Fremont, Ohio, Verenigde Staten, 43420
        • Fremont Memorial Hospital
      • Greenville, Ohio, Verenigde Staten, 45331
        • Wayne Hospital
      • Kenton, Ohio, Verenigde Staten, 43326
        • Cole, Sharon, K. M.D. (UIA Investigator)
      • Kettering, Ohio, Verenigde Staten, 45429
        • Kettering Medical Center
      • Lima, Ohio, Verenigde Staten, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Verenigde Staten, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, Verenigde Staten, 43537-1839
        • Northwest Ohio Oncology Center
      • Maumee, Ohio, Verenigde Staten, 43537
        • Saint Luke's Hospital
      • Oregon, Ohio, Verenigde Staten, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Verenigde Staten, 43616
        • Bayview Oncology Associates
      • Sandusky, Ohio, Verenigde Staten, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, Verenigde Staten, 44870
        • Firelands Regional Medical Center
      • Sylvania, Ohio, Verenigde Staten, 43560
        • Flower Memorial Hospital
      • Tiffin, Ohio, Verenigde Staten, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Verenigde Staten, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, Verenigde Staten, 43614
        • University of Toledo
      • Toledo, Ohio, Verenigde Staten, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Verenigde Staten, 43606
        • The Toledo Hospital
      • Toledo, Ohio, Verenigde Staten, 43623
        • Toledo Clinic
      • Toledo, Ohio, Verenigde Staten, 43623
        • Stark, Michael, Edward. M.D. (UIA Investigator)
      • Toledo, Ohio, Verenigde Staten, 43623
        • Mercy Cancer Center at Saint Anne Mercy Hospital
      • Troy, Ohio, Verenigde Staten, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, Verenigde Staten, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, Verenigde Staten, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, Verenigde Staten, 45385
        • Greene Memorial Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Verenigde Staten, 18105
        • Lehigh Valley Hospital
      • Danville, Pennsylvania, Verenigde Staten, 17822-2001
        • Geisinger Medical Center
      • State College, Pennsylvania, Verenigde Staten, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
        • Geisinger Wyoming Valley
    • South Carolina
      • Anderson, South Carolina, Verenigde Staten, 29621
        • AnMed Health Hospital
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Upstate Carolina CCOP
    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Avera McKennan Hospital and University Health Center
    • Virginia
      • Fredericksburg, Virginia, Verenigde Staten, 22401
        • Fredericksburg Oncology Inc
    • Wyoming
      • Sheridan, Wyoming, Verenigde Staten, 82801
        • Welch Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: rituximab
375 mg/m^2 Given IV
Andere namen:
  • Rituxan
  • Mabthera
  • IDEC-C2B8
  • IDEC-C2B8 monoklonaal antilichaam
  • MOAB IDEC-C2B8
Geneesmiddel: temsirolimus
25 mg given IV
Andere namen:
  • Torisel
  • CCI-779
  • celcyclusremmer 779

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
Tijdsspanne: Up to 12, 28-day cycles.

Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.

Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.

Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.

We report the Overall Response Rate here.
Up to 12, 28-day cycles.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Progression
Tijdsspanne: Patients were followed up to five years after registration.
Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Patients were followed up to five years after registration.
Duration of Response
Tijdsspanne: Response duration is followed up to 5 years from registration.
Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Response duration is followed up to 5 years from registration.
Toxicity
Tijdsspanne: Assessed during treatment (up to 12, 28-day cycles)

As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.

In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event.
Assessed during treatment (up to 12, 28-day cycles)
Overall Survival
Tijdsspanne: Patients were followed for survival status for up to 5 years.
Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Patients were followed for survival status for up to 5 years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Stephen Ansell, North Central Cancer Treatment Group

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2005

Primaire voltooiing (Werkelijk)

1 september 2009

Studie voltooiing (Werkelijk)

1 maart 2012

Studieregistratiedata

Eerst ingediend

3 mei 2005

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2005

Eerst geplaatst (Schatting)

4 mei 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

17 april 2014

Laatste update ingediend die voldeed aan QC-criteria

21 maart 2014

Laatst geverifieerd

1 december 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2009-00644
  • U10CA025224 (Subsidie/contract van de Amerikaanse NIH)
  • N038H
  • CDR0000425334 (Register-ID: PDQ (Physician Data Query))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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