Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Status: | |
---|---|
Conditions: | Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | June 2006 |
A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as
alemtuzumab, 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 combination chemotherapy together with alemtuzumab
may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic
leukemia.
OBJECTIVES:
- Determine the complete response rate in patients with relapsed or refractory acute
lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and
dexamethasone in combination with alemtuzumab.
- Determine disease-free and/or overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Correlate the density of CD52 molecules on the surface of leukemic lymphoblasts with
response in patients treated with this regimen.
- Correlate the presence of minimal residual disease at the time of maximal response to
this regimen with overall outcome in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive methotrexate IV on day 1; vincristine IV and
asparaginase intramuscularly (IM) on day 2; oral dexamethasone on days 1-10; and
alemtuzumab subcutaneously on days 1, 4, and 7. Treatment repeats every 10 days for 6
courses in the absence of disease progression or unacceptable toxicity. Patients who
achieve complete remission (CR) proceed to consolidation therapy.
- Consolidation therapy: Patients receive methotrexate IV on day 1 and asparaginase IM on
day 2. Treatment repeats every 10 days for 6 courses in the absence of disease
progression or unacceptable toxicity. Patients who remain in CR proceed to
cytoreduction therapy.
- Cytoreduction therapy: Patients receive vincristine IV and methotrexate IV over 6 hours
on day 1; leucovorin calcium IV continuously over 24 hours on days 1 and 2 and then
orally 4 times a day on day 3; and oral dexamethasone on days 2-6. Treatment repeats
every 30 days for 12 courses in the absence of disease progression or unacceptable
toxicity. Patients who remain in CR proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral mercaptopurine on days 1-30; oral
methotrexate on days 1, 8, 15, and 22; vincristine IV on day 1; and oral dexamethasone
on days 1-5. Treatment repeats every 30 days for 36 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years from the
date of registration to this study.
PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Refractory or relapsed acute lymphoblastic leukemia
- Must be in first relapse or have failed to achieve complete remission with 1
prior regimen
- Prior CNS leukemia allowed provided cerebrospinal fluid is normal
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin normal
- No hepatitis B positivity
Renal
- Creatinine normal
Immunologic
- HIV negative
- No bacterial or fungal infection
- No infection requiring treatment with antibiotics
- No active cytomegalovirus infection by molecular detection methods
- No known hypersensitivity to alemtuzumab or its components
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell skin
cancer or cervical carcinoma
PRIOR CONCURRENT THERAPY:
- Not specified
We found this trial at
64
sites
100 Provena Way
Kankakee, Illinois 60914
Kankakee, Illinois 60914
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
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Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 262-5223
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center UW Carbone Cancer Center holds the...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
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Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Union Hospital of Cecil County Union Hospital is an award-winning, full-service community hospital located in...
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550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
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Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
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Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
Libertyville, Illinois 60048
847-367-6781
North Shore Oncology and Hematology Associates, Limited - Libertyville Welcome to North Shore Oncology and...
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St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
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Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
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1575 Beam Avenue
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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701 Park Ave
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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Morgantown, West Virginia 26506
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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8915 W Golf Rd
Niles, Illinois 60714
Niles, Illinois 60714
(847) 827-9060
Cancer Care and Hematology Specialists of Chicagoland - Niles Illinois Cancer Specialists is dedicated to...
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Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Metro-Minnesota CCOP The Metro-Minnesota Community Clinical Oncology (MMCCOP) was established in 1979 through an NCI-funded...
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Park Nicollet Cancer Center Park Nicollet Methodist Hospital has a long and rich history in...
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United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Mercy Medical Center - Sioux City Living the traditions, visions and values of the Sisters...
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Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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St. Luke's Regional Medical Center St. Luke's is a patient and family-centered hospital that delivering...
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Hematology Oncology Associates of Illinois At Hematology Oncology Associates of Illinois, our goal is to...
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Regions Hospital Cancer Care Center Established in 1872, Regions Hospital is a private, not-for-profit organization....
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200 Scenery Drive
State College, Pennsylvania 16801
State College, Pennsylvania 16801
814-231-4560
Geisinger Medical Group - Scenery Park Geisinger-Scenery Park provides an impressive array of healthcare right...
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Mount Nittany Medical Center Mount Nittany Medical Center is a 260-bed acute care facility offering...
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Lakeview Hospital At Lakeview Hospital, our Mission is to provide the quality of healthcare we...
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Ridgeview Medical Center Ridgeview Medical Center is an independent, nonprofit, regional health care system located...
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Cancer Center of Kansas, PA - Wellington Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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3243 East Murdock, Suite 300
Wichita, Kansas 67208
Wichita, Kansas 67208
(316) 262-4467
Cancer Center of Kansas-Wichita Medical Arts Tower Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Wichita CCOP The Wichita Community Clinical Oncology Program (CCOP), which first received funding by NCI...
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8710 W 13th St N # 100
Wichita, Kansas 67208
Wichita, Kansas 67208
(316) 722-5141
Associates in Womens Health, PA - North Review On January 1, 1997, four prominent practices,...
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1000 E. Mountain Blvd.
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
570-808-6150
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center The Frank...
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301 Becker Ave SW
Willmar, Minnesota 56201
Willmar, Minnesota 56201
(320) 231-4570
Willmar Cancer Center at Rice Memorial Hospital As a Community Hospital Cancer Program approved by...
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Cancer Center of Kansas, PA - Winfield Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Minnesota Oncology - Woodbury We understand that a diagnosis of cancer is immensely stressful to...
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