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CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: May 3, 2005   Last Updated: April 14, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109967
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: temsirolimus
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete, partial, and unconfirmed) during the first 24 weeks of treatment as defined by the International Workshop criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Time to event analysis of response [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 73
Study Start Date: May 2005
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab.
  • Determine the tolerability of this regimen in these patients.
  • Determine adverse events in patients treated with this regimen.

Secondary

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

PROJECTED ACCRUAL: A total of 40-73 patients (24-45 in stratum 1 and 16-28 in stratum 2) will be accrued for this study within approximately 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 NOTE: *By peripheral blood flow cytometry and/or bone marrow aspirate and biopsy for patients who have had a prior excisional biopsy; patients who have had intervening treatment since last biopsy are required to have a rebiopsy
  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3

Hepatic

  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin < 1.5 times ULN
  • AST ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)

Renal

  • Creatinine ≤ 2 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • Prior chemotherapy allowed
  • No other concurrent chemotherapy

Endocrine therapy

  • 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

Radiotherapy

  • Prior radiotherapy allowed

Surgery

  • Not specified

Other

  • No prior treatment with a mTOR inhibitor
  • No other concurrent investigational or commercial agents or therapies for MCL
  • No other concurrent immunosuppressive therapy
  • No other concurrent treatment for MCL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109967

  Hide Study Locations
Locations
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
McKee Medical Center
Loveland, Colorado, United States, 80539
North Colorado Medical Center
Greeley, Colorado, United States, 80631
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Swedish Medical Center
Englewood, Colorado, United States, 80110
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
United States, Indiana
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
United Hospital
Saint Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Great Falls, Montana, United States, 59405
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Montana Hospital
Havre, Montana, United States, 59501
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
MeritCare Broadway
Fargo, North Dakota, United States, 58122
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Wayne Hospital
Greenville, Ohio, United States, 45331
Toledo Hospital
Toledo, Ohio, United States, 43606
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Pennsylvania
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Stephen M. Ansell, MD, PhD Mayo Clinic
Investigator: Scott H. Kaufmann, MD, PhD Mayo Clinic
Investigator: Radha M. Rao, MD Siouxland Hematology-Oncology Associates, LLP
  More Information

Additional Information:
Publications:
Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000425334, NCCTG-N038H
Study First Received: May 3, 2005
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00109967     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009