Spots Global Cancer Trial Database for Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
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Trial Identification
Brief Title: Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Official Title: Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
Study ID: NCT00074282
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
Detailed Description: OBJECTIVES: Primary * Determine the objective response rate (complete remission, partial remission \[PR\], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by CAMPATH-1H . * Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR Secondary * Determine the toxicity of this regimen in these patients. * Determine the overall and progression-free survival of patients treated with this regimen. * Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR, SD, or PD and who subsequently convert to a higher response category after CAMPATH-1H . Exploratory * Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular density by immunohistochemistry) at baseline, after PCR, after CAMPATH-1H, every six months (serum only), and at time of response assessment (marrow). * Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome. * Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel) information on CLL-B cell clones and associate with clinical outcome. * Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Anthony Central Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Kellogg Cancer Care Center, Highland Park, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States
Swedish-American Regional Cancer Center, Rockford, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Ochsner Health Center - Bluebonnet, Baton Rouge, Louisiana, United States
Ochsner Health Center - Covington, Covington, Louisiana, United States
New Orleans Cancer Institute at Memorial Medical Center, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Beth Israel Medical Center - Petrie Division, New York, New York, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital, Fargo, North Dakota, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
St. Rita's Medical Center, Lima, Ohio, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Marshfield Clinic - Chippewa Center, Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Saint Joseph's Hospital, Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
St. Nicholas Hospital, Sheboygan, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Sanford J. Kempin, MD
Affiliation: Beth Israel Medical Center
Role: STUDY_CHAIR
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