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

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

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
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...
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
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...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
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...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
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....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
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...
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
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...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
9981 South Healthpark Drive
Fort Myers, Florida 33908
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
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,...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
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,...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
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...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
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...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
1000 Joe DiMaggio Drive
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
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...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
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...
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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....
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
2501 N Orange Ave # 235
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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...
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
2801 North Gantebein Ave.
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
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...
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
1465 South Grand Blvd
St. Louis, Missouri 63104
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
345 Smith Ave N # 302
St. Paul, Minnesota 55102
?
mi
from
St. Paul, MN
Click here to add this to my saved trials
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...
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
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...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
?
mi
from
Boise, ID
Click here to add this to my saved trials
100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Antonio, Texas 78207
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Tampa, Florida 33682
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials
6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
?
mi
from
Washington,
Click here to add this to my saved trials