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

Use our guide to learn which trials are right for you!

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
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
?
mi
from
Kankakee, IL
Click here to add this to my saved trials
2600 6th Street Southwest
Canton, Ohio 44710
330-452-9911
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
?
mi
from
Canton, OH
Click here to add this to my saved trials
675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
?
mi
from
Hershey, PA
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
?
mi
from
Lewes, DE
Click here to add this to my saved trials
600 Highland Ave.
Madison, Wisconsin 53792
(608) 262-5223
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center UW Carbone Cancer Center holds the...
?
mi
from
Madison, WI
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45236
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
Dodge City, KS
Click here to add this to my saved trials
6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
?
mi
from
Edina, MN
Click here to add this to my saved trials
700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
El Dorado, KS
Click here to add this to my saved trials
106 Bow St
Elkton MD, Maryland 21921
(410) 398-4000
Union Hospital of Cecil County Union Hospital is an award-winning, full-service community hospital located in...
?
mi
from
Elkton MD, MD
Click here to add this to my saved trials
550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
?
mi
from
Fridley, MN
Click here to add this to my saved trials
1740 E Broad St
Hazleton, Pennsylvania 18201
(570) 459-2901
Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
?
mi
from
Hazleton, PA
Click here to add this to my saved trials
Highland Park, Illinois 60035
?
mi
from
Highland Park, IL
Click here to add this to my saved trials
1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
?
mi
from
Hutchinson, MN
Click here to add this to my saved trials
?
mi
from
Joliet, IL
Click here to add this to my saved trials
1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Kingman, KS
Click here to add this to my saved trials
325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
?
mi
from
Lawrence, KS
Click here to add this to my saved trials
400 Highland Ave
Lewistown, Pennsylvania 17044
(717) 248-5411
Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
?
mi
from
Lewistown, PA
Click here to add this to my saved trials
1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
847-367-6781
North Shore Oncology and Hematology Associates, Limited - Libertyville Welcome to North Shore Oncology and...
?
mi
from
Libertyville, IL
Click here to add this to my saved trials
730 W Market St
Lima, Ohio 45801
(419) 227-3361
St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
?
mi
from
Lima, OH
Click here to add this to my saved trials
1580 Beam Ave
Maplewood, Minnesota 55109
(651) 779-7978
Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
1575 Beam Avenue
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
701 Park Ave
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Newton, KS
Click here to add this to my saved trials
8915 W Golf Rd
Niles, Illinois 60714
(847) 827-9060
Cancer Care and Hematology Specialists of Chicagoland - Niles Illinois Cancer Specialists is dedicated to...
?
mi
from
Niles, IL
Click here to add this to my saved trials
1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Parsons, KS
Click here to add this to my saved trials
124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Pratt, KS
Click here to add this to my saved trials
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
3800 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
(952) 993-1516
Metro-Minnesota CCOP The Metro-Minnesota Community Clinical Oncology (MMCCOP) was established in 1979 through an NCI-funded...
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
(952) 993-3248
Park Nicollet Cancer Center Park Nicollet Methodist Hospital has a long and rich history in...
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
600 S Santa Fe Ave
Salina, Kansas 67401
(785) 823-1521
Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Salina, KS
Click here to add this to my saved trials
801 5th St
Sioux City, Iowa 51104
(712) 279-2010
Mercy Medical Center - Sioux City Living the traditions, visions and values of the Sisters...
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
2720 Stone Park Blvd
Sioux City, Iowa 51104
(712) 279-3500
St. Luke's Regional Medical Center St. Luke's is a patient and family-centered hospital that delivering...
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
9711 Skokie Blvd
Skokie, Illinois 60077
(847) 568-9930
Hematology Oncology Associates of Illinois At Hematology Oncology Associates of Illinois, our goal is to...
?
mi
from
Skokie, IL
Click here to add this to my saved trials
640 Jackson Street
St. Paul, Minnesota 55101
651-254-3456
Regions Hospital Cancer Care Center Established in 1872, Regions Hospital is a private, not-for-profit organization....
?
mi
from
St. Paul, MN
Click here to add this to my saved trials
200 Scenery Drive
State College, Pennsylvania 16801
814-231-4560
Geisinger Medical Group - Scenery Park Geisinger-Scenery Park provides an impressive array of healthcare right...
?
mi
from
State College, PA
Click here to add this to my saved trials
1800 E Park Ave
State College, Pennsylvania 16803
(814) 231-7000
Mount Nittany Medical Center Mount Nittany Medical Center is a 260-bed acute care facility offering...
?
mi
from
State College, PA
Click here to add this to my saved trials
630 Medical Dr
Stillwater, Minnesota 84010
(801) 299-2200
Lakeview Hospital At Lakeview Hospital, our Mission is to provide the quality of healthcare we...
?
mi
from
Stillwater, MN
Click here to add this to my saved trials
500 S Maple Street
Waconia, Minnesota 55387
952-442-2191
Ridgeview Medical Center Ridgeview Medical Center is an independent, nonprofit, regional health care system located...
?
mi
from
Waconia, MN
Click here to add this to my saved trials
1323 N. A
Wellington, Kansas 67152
(620) 326-7453 Ext. 224
Cancer Center of Kansas, PA - Wellington Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Wellington, KS
Click here to add this to my saved trials
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
3243 East Murdock, Suite 300
Wichita, Kansas 67208
(316) 262-4467
Cancer Center of Kansas-Wichita Medical Arts Tower Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
929 N St Francis Street
Wichita, Kansas 67214
(316) 262-4467
Wichita CCOP The Wichita Community Clinical Oncology Program (CCOP), which first received funding by NCI...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
8710 W 13th St N # 100
Wichita, Kansas 67208
(316) 722-5141
Associates in Womens Health, PA - North Review On January 1, 1997, four prominent practices,...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1000 E. Mountain Blvd.
Wilkes-Barre, Pennsylvania 18711
570-808-6150
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center The Frank...
?
mi
from
Wilkes-Barre, PA
Click here to add this to my saved trials
301 Becker Ave SW
Willmar, Minnesota 56201
(320) 231-4570
Willmar Cancer Center at Rice Memorial Hospital As a Community Hospital Cancer Program approved by...
?
mi
from
Willmar, MN
Click here to add this to my saved trials
1305 E 5th Ave
Winfield, Kansas 67156
(620) 221-6125
Cancer Center of Kansas, PA - Winfield Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Winfield, KS
Click here to add this to my saved trials
6025 Lake Road, Suite 110
Woodbury, Minnesota 55125
(651) 735-7414
Minnesota Oncology - Woodbury We understand that a diagnosis of cancer is immensely stressful to...
?
mi
from
Woodbury, MN
Click here to add this to my saved trials