Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Blood Cancer, Cardiology, Lymphoma
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:Any
Updated:2/23/2019
Start Date:August 5, 2013

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Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated
with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in
the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more
about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand
how well patients respond to treatment.

PRIMARY OBJECTIVES:

I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana
Farber Cancer Institute (DFCI) 95-01 randomized to the experimental dexrazoxane hydrochloride
(DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with
patients on the standard arm.

II. To determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased
markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma
patients diagnosed during the same time period, but who did not receive DRZ.

III. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline
(anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at
cancer diagnosis, current age, sex).

SECONDARY OBJECTIVES:

I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI
95-01 on the DRZ arms experienced differential rates of overall-survival and event-free
survival compared with the standard therapy arms.

II. To determine whether projected quality-adjusted life years (QALY) differed by DRZ status,
accounting for premature cardiac disease, primary disease relapse, and second cancers.

OUTLINE:

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram,
collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of
life, family history, physical activity, and smoking questionnaires.

Inclusion Criteria:

- STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS

- Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on
P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)

- STRATUM I: Alive and in continuous first complete remission from their original cancer
(leukemia/lymphoblastic lymphoma [P9404, high-risk DFCI 95-01] or Hodgkin lymphoma
[P9425/P9426])

- STRATUM I: Did not have progressive disease or induction failure requiring
off-protocol therapy including hematopoietic cell transplantation

- STRATUM I: Must not have been diagnosed with any subsequent malignancy that required
additional cardiotoxic therapies (i.e., radiotherapy to the chest [also includes
fields directed towards the neck, upper abdomen, or spine], or additional
anthracyclines or anthraquinones); patients with history of subsequent malignancy that
did not require such therapies remain eligible

- STRATUM I: All patients and/or their parents or legal guardians must sign a written
informed consent

- STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404,
P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have
experienced a subsequent malignancy that precludes eligibility since their original
diagnosis, the study committee will review the available data (both from Children's
Oncology Group's [COG?s] Statistics and Data Center [SDC] and the participating
institution) to determine if individual patients are to be selected for Stratum 2; in
recognition that local institutions sometimes have more updated relapse/subsequent
cancer data than SDC, in cases where local data is more updated, local data will be
used preferentially; the study will petition the Institutional Review Board (IRB)
specifically for a waiver of consent to include any relapse and subsequent cancer data
obtained from existing records for analysis of the secondary aims; patients selected
for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but
who lack clear confirmation in existing records (either at SDC or at the local
institution)

- STRATUM II: Alive, but have experienced relapse of their original cancer and/or have
developed a subsequent cancer (other than non-melanomatous skin cancer) since their
original diagnosis

- STRATUM II: All patients and/or their parents or legal guardians must sign a written
informed consent

- STRATUM III: OSTEOSARCOMA SURVIVORS

- Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able
(themselves and/or parents/legal guardian) to provide written informed consent; note
that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors

- Comparison subjects for P9754 survivors will be eligible to be enrolled from any
ALTE11C2 participating COG site (even if that institution did not participate on
P9754), according to the following criteria:

- Newly diagnosed, previously untreated biopsy-proven moderate or high grade
osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal
or periosteal sarcoma are ineligible

- < 31 years of age at time of initial osteosarcoma diagnosis

- Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of
therapy can extend beyond 2002

- No evidence of poor or low cardiac function at time of initial osteosarcoma
diagnosis; if reports from the time are available: shortening fraction >= 28% by
echocardiogram and within the institutional normative range for age, or
radionuclide angiogram ejection fraction >= 50%; if imaging reports from the time
are no longer available, there must be no documentation within available medical
records that suggest poor or low cardiac function at time of diagnosis

- Comparison subject must have institutional records (e.g., clinic note, treatment
summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m^2
of doxorubicin (doses within 10% are acceptable); this includes initial therapy
as well as any subsequent therapy for relapse or second cancer, if relevant; as
such, comparison subjects who have had osteosarcoma relapse or subsequent
malignancies remain eligible so long as they meet all other eligibility criteria

- No anthracycline or anthraquinone aside from doxorubicin was ever given as part
of initial or subsequent therapies

- No exposure to DRZ at any point in time

- All patients and/or their parents or legal guardians must sign a written informed
consent

- For all participants, all institutional, Food and Drug Administration (FDA), and
National Cancer Institute (NCI) requirements for human studies must be met
We found this trial at
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: John F. Kuttesch
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1600 7th Avenue
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666 Elm Street
Buffalo, New York 14263
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1 South Prospect Street
Burlington, Vermont 05401
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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7777 Forest Ln # C840
Dallas, Texas 75230
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
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1 Hurley Plaza
Flint, Michigan 48503
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2500 N State St
Jackson, Mississippi 39216
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530 Northeast Glen Oak Avenue
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(309) 624-4945
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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593 Eddy Street
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401 College Street
Richmond, Virginia 23298
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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4502 Medical Drive
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
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2401 W Belvedere Ave
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401 North Broadway
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450 Brookline Ave
Boston, Massachusetts 2215
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171 Ashley Avenue
Charleston, South Carolina 29425
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Chicago, Illinois 60614
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1200 West Harrison Stree
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Columbia, Missouri 65201
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Dallas, Texas 75390
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
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Detroit, Michigan 48236
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Fort Myers, Florida 33908
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801 7th Avenue
Fort Worth, Texas 76104
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1600 Southwest Archer Road
Gainesville, Florida 32610
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Hollywood, Florida 33021
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Honolulu, Hawaii 96813
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
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Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Houston, Texas 77030
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Las Vegas, Nevada 89109
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Las Vegas, Nevada 89135
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Madera, California 93638
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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New Haven, Connecticut 6520
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New Hyde Park, New York 11040
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Oak Lawn, Illinois 60453
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
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Perth, Western Australia
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3601 A St
Philadelphia, Pennsylvania 19134
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Portland, Oregon 97227
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Saint Petersburg, Florida 33701
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Scarborough, Maine 04074
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
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101 W 8th Ave
Spokane, Washington 99204
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
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Syracuse, New York 13214
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Tampa, Florida 33607
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Tucson, Arizona 85724
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901 45th St
West Palm Beach, Florida 33407
(561) 844-6300
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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