Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients Receiving Vincristine for Wilms' Tumor, Rhabdomyosarcoma, Acute Lymphoblastic Leukemia, or Non-Hodgkin's Lymphoma



Status:Recruiting
Conditions:Cancer, Cancer, Blood Cancer, Lymphoma, Neurology, Kidney Cancer, Leukemia
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 20
Updated:3/30/2013
Start Date:May 2007

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Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer [ACCL0731]


RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It
is not yet known whether glutamic acid is more effective than a placebo in preventing nerve
damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute
lymphoblastic leukemia, or non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works
compared to a placebo in reducing nerve damage caused by vincristine in young patients
receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or
non-Hodgkin's lymphoma.


OBJECTIVES:

Primary

- Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as
measured by a scored neurologic examination, in young patients undergoing
vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute
lymphoblastic leukemia, or non-Hodgkin's lymphoma.

Secondary

- Compare the frequency and types of neurotoxicity observed in patients treated with
glutamic acid versus placebo.

- Determine if a greater proportion of patients receiving glutamic acid are able to
receive 100% of their scheduled doses of vincristine versus those not treated with
glutamic acid.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease and duration of planned vincristine-containing treatment
(Wilms' tumor or rhabdomyosarcoma with treatment planned for ≥ 9 consecutive weeks [stratum
1] vs acute lymphoblastic leukemia or non-Hodgkin's lymphoma with treatment planned for ≥ 4
consecutive weeks [stratum 2]). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral glutamic acid 3 times daily beginning prior to the first
dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of
vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.

- Arm II: Patients receive oral placebo 3 times daily beginning prior to the first dose
of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of
vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.

All patients undergo neurologic examination at baseline and at 5 weeks. Patients in stratum
1 also undergo additional neurologic examination at week 10.

PROJECTED ACCRUAL: A total of 208 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Undergoing vincristine-containing treatment for any of the following newly diagnosed
malignancies:

- Wilms' tumor or rhabdomyosarcoma

- Scheduled to receive ≥ 9 consecutive weeks of vincristine-containing
chemotherapy regimen

- Acute lymphoblastic leukemia or non-Hodgkin's lymphoma

- Scheduled to receive ≥ 4 consecutive weeks of vincristine-containing
chemotherapy regimen and concurrent steroid therapy

- No underlying neuromuscular disease or peripheral neuropathy

- Normal baseline peripheral neurologic exam

- No primary intracranial malignancy

PATIENT CHARACTERISTICS:

- No seizure disorders

- No family history of Charcot-Marie-Tooth disease

- No recent history of Guillain-Barre syndrome

PRIOR CONCURRENT THERAPY:

- No concurrent itraconazole

- No regular use of laxatives or stool softeners prophylactically for constipation
prior to chemotherapy

- No concurrent enrollment on another investigational protocol involving a study agent
that is provided under an IND
We found this trial at
44
sites
501 6th Ave S
Saint Petersburg, Florida 33701
(727) 898-7451
All Children's Hospital All Children's Hospital provides expert pediatric care for children and families from...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1405 Clifton Road Northeast
Atlanta, Georgia 30322
(404) 785-6000
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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9981 South Healthpark Drive
Fort Myers, Florida 33908
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2776 Cleveland Ave
Fort Myers, Florida 33905
(239) 343-9500
Lee Cancer Care of Lee Memorial Health System Our origins can be traced to the...
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801 Seventh Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center - Fort Worth Cook Children's Health Care System is a not-for-profit,...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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30 Prospect Avenue
Hackensack, New Jersey 07601
(201) 996-5900
Hackensack University Medical Center Cancer Center The mission of the John Theurer Cancer Center is...
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1000 Joe DiMaggio Drive
Hollywood, Florida 33021
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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701 E 28th St # 202
Long Beach, California 90806
(562) 933-8600
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital JCCC has comprehensive psychosocial programs and...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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2501 N Orange Ave # 235
Orlando, Florida 32804
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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2801 North Gantebein Ave.
Portland, Oregon 97227
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1465 South Grand Blvd
St. Louis, Missouri 63104
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345 Smith Ave N # 302
St. Paul, Minnesota 55102
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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100 Michigan St NE
Grand Rapids, Michigan 49503
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Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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1319 Punahou St
Honolulu, Hawaii 96826
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Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
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Los Angeles, California 90095
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2525 Chicago Ave
Minneapolis, Minnesota 55404
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195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
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200 First Street SW
Rochester, Minnesota 55905
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Temple, Texas 76508
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
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