Full Text View
Tabular View
No Study Results Posted
Related Studies
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
This study has been completed.
First Received: April 9, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033267
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: temsirolimus
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response (complete and partial) during first 24 weeks of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Study Start Date: April 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779.
  • Determine the toxic effects of this drug in these patients.
  • Determine whether this drug inhibits cell proliferation pathways in these patients.

OUTLINE: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR.

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 maximum of 27 patients will be accrued for this study within 2 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 non-Hodgkin's lymphoma (MCL)
  • Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
  • Unidimensionally measurable lymph node or lesion

    • At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
    • One of the following measurement parameters may be used:

      • Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
      • Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3
  • No known CNS involvement (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
  • Hemoglobin ≥ 8 g/dL

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 metastases are present)

Renal:

  • Creatinine ≤ 2 times ULN

Cardiovascular:

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

Other:

  • Cholesterol ≤ 350 mg/dL
  • Triglycerides ≤ 400 mg/dL
  • HIV negative
  • No other active malignancy requiring treatment or that would preclude study participation
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • Prior high-dose therapy with stem cell transplantation allowed
  • At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers

Chemotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy for MCL

Endocrine therapy:

  • Concurrent corticosteroids for adrenal insufficiency allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy for MCL

Surgery:

  • Not specified

Other:

  • Any number of prior treatments allowed
  • No other concurrent investigational or commercial agents for MCL
  • No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
  • No concurrent immunosuppressive therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033267

  Hide Study Locations
Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259
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
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
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
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Oncology/Hematology Associates of Central Illinois, P.C.
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, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
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
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Siouxland Hematology-Oncology Associates
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
Wichita, Kansas, United States, 67203
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
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, 48100
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48532
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Hurley Medical Center
Flint, Michigan, United States, 48502
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
St. John Macomb Hospital
Warren, Michigan, United States, 48903
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
United States, Minnesota
Adult and Pediatric Urology, P.L.L.P.
St. Cloud, Minnesota, United States, 56303
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, United States, 55432
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States, 56265
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Alexandria, Minnesota, United States, 56308
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55403
Fergus Falls, Minnesota, United States, 56537
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Alexandria, Minnesota, United States, 56308
United States, Montana
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Judy L. Schmidt, MD, FACP, P. C.
Missoula, Montana, United States, 59804
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59802
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, Nebraska
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
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
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
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, 43623
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Toledo Hospital
Toledo, Ohio, United States, 43606
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
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, Incorporated
Toledo, Ohio, United States, 43623
Toledo Clinic
Oregon, Ohio, United States, 43616
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Wisconsin
Central Wisconsin Cancer Program at Agnesian Health Care
Fond Du Lac, Wisconsin, United States, 54935
Franciscan Skemp Healthcare
La Crosse, Wisconsin, United States, 54601
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Stephen M. Ansell, MD, PhD Mayo Clinic
  More Information

Additional Information:
Publications:
Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Jun 9; [Epub ahead of print]
Witzig TE, Ansell SM, Geyer SM, et al.: Anti-tumor activity of low-dose single agent CCI-779 for relapsed mantle cell lymphoma: a phase II trial in the North Central Cancer Treatment Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-6504, 561s, 2005.
Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. Epub 2005 Jun 27.
Witzig T, Geyer S, Ghobrial I, et al.: Anti-tumor activity of single-agent CCI-779 for relapsed mantle cell lymphoma: a phase II trial in the North Central Cancer Treatment Group. [Abstract] Blood 104 (11): A-129, 2004.
Witzig TE, Geyer SM, Salim M, et al.: A phase II trial of the rapamycin analog CCI-779 in previously treated mantle cell non-Hodgkins lymphoma: interim analysis of 18 patients. [Abstract] Blood 102 (11 Pt 1): A-2374, 2003.

Study ID Numbers: CDR0000069269, NCCTG-N0186
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033267     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009