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| 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 |
| Estimated Enrollment: | 73 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed* mantle cell lymphoma (MCL)
Measurable disease, defined as ≥ 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids to induce an antitumor response
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study 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 | |
| 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
| 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 |
|
recurrent mantle cell lymphoma |
|
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 |