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RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Cardiac Toxicity, Lymphoma

Thank you

Trial Information

RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY


OBJECTIVES: I. Modify chemotherapy courses based on initial response to therapy in children
with newly diagnosed stage IA/IIA/IIIA1 Hodgkin's disease. II. Examine the activity of
variable courses of doxorubicin, bleomycin, vincristine, and etoposide (DBVE) followed by
low-dose involved-field irradiation in these patients. III. Monitor the safety and
feasibility of the response-dependent approach and the morbidity and immediate and long-term
toxic effects associated with this regimen. IV. Assess whether limited therapy is adequate
for patients with an early response. V. Evaluate whether the addition of dexrazoxane can
reduce pulmonary toxicity while not significantly reducing the response rate or event-free
survival. VI. Evaluate whether the frequency and magnitude of myocardial injury during
therapy, as measured by elevated serum cardiac troponin-T, is reduced by the addition of
dexrazoxane.

OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to receive doxorubicin, bleomycin, vincristine, etoposide,
and filgrastim with vs. without dexrazoxane. Filgrastim SC begins on days 6-13; no
filgrastim is given on day 14 or 15. Filgrastim will restart 2 days after completing therapy
and continue until count recovery from expected nadir (ANC greater than 1000 cubic meter
after nadir). Courses repeat every 28 days. Those with stable or responding disease after
2-4 courses receive involved-field radiotherapy 5 days per week for 3.5 weeks. Tanner stage
IV/V patients are eligible for randomization based on a front-end institutional agreement
and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the
investigator's discretion. Patients are followed yearly until relapse, death, or for a
minimum of 10 years.

PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study over 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease No more than 5 weeks
since diagnostic biopsy No B symptoms Clinical/pathologic stages (all histologies) as
follows: Stage IA/IIA with mediastinal mass less than one third of chest diameter Stage
IIIA limited to spleen or splenic, celiac, or portal nodes and lesions no larger than 6 cm
Surgical staging required if: Clinical and imaging findings equivocal Tanner stage IV/V
for whom radiotherapy is planned Concurrent registration on protocols POG-8828 (late
effects study) and POG- 8829 (epidemiology study) required

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified
Hematopoietic: No hematopoietic disease Hepatic: No liver disease Renal: No renal disease
Other: No severe organ or system damage or failure No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Cameron K. Tebbi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Joseph's Children's Hospital of Tampa

Authority:

United States: Federal Government

Study ID:

CDR0000065013

NCT ID:

NCT00002827

Start Date:

October 1996

Completion Date:

Related Keywords:

  • Cardiac Toxicity
  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • cardiac toxicity
  • Hodgkin Disease
  • Lymphoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
Huntsman Cancer InstituteSalt Lake City, Utah  84112
David Grant Medical CenterTravis Air Force Base, California  94535
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Children's Mercy Hospital - Kansas CityKansas City, Missouri  64108