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Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy


OBJECTIVES: I. Determine the feasibility and toxicity of bleomycin, etoposide, doxorubicin,
cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) induction in pediatric
patients with previously untreated stage II, stage III, or stage IV Hodgkin's disease. II.
Determine rates of complete response and rapid early partial response (defined as greater
than 70% reduction in the size of a bulky mediastinal mass or nodal aggregate and a negative
gallium scan) in these patients treated with 4 courses of BEACOPP. III. Determine whether
thallium scans effectively measure response to therapy in these patients treated with this
regimen. IV. Evaluate the expression of markers of apoptosis in tumor samples from these
patients at diagnosis and at time of relapse, and correlate expression of these markers with
response to therapy and overall outcome. V. Determine the utility of seven molecular genetic
markers as surrogate markers of genotoxic damage caused by this regimen in these patients.
VI. Estimate the incidence of therapy related late effects, including second malignant
neoplasms, sterility, cardiac dysfunction, pulmonary restrictive disease, growth
abnormalities, and thyroid disease in these patients.

OUTLINE: Induction: On day 0, patients receive cyclophosphamide IV over 30 minutes,
doxorubicin IV over 15-30 minutes, etoposide IV over 1 hour, oral prednisone every 12 hours,
and oral procarbazine. On days 1 and 2, patients receive etoposide IV over 1 hour, oral
prednisone every 12 hours, and oral procarbazine. On days 3-6, patients receive oral
prednisone every 12 hours and oral procarbazine. On day 7, patients receive vincristine IV,
bleomycin IV over 5 minutes, and oral prednisone every 12 hours. On days 8-13, patients
receive oral prednisone every 12 hours. Beginning on day 8, patients receive filgrastim
(G-CSF) subcutaneously until absolute neutrophil counts recover. Treatment repeats every 3
weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Consolidation therapy begins on week 12 or when blood counts recover. Consolidation for
rapid early responders (patients with complete response (CR) or rapid early partial response
(PR-1) to induction therapy): Females - Patients receive vincristine IV, cyclophosphamide IV
over 30 minutes, oral prednisone every 12 hours, and oral procarbazine on day 0. On days
1-6, patients receive oral prednisone every 12 hours and oral procarbazine. On day 7,
patients receive vinblastine IV, bleomycin IV over 5 minutes, doxorubicin IV over 15-30
minutes, and oral prednisone every 12 hours. On days 8-13, patients receive oral prednisone
every 12 hours. Treatment repeats every 28 days for a total of 4 courses in the absence of
disease progression or unacceptable toxicity. Males - Patients receive doxorubicin IV over
15-30 minutes, bleomycin IV over 5 minutes, vinblastine IV, and dacarbazine IV on days 0 and
14. Treatment repeats every 28 days for a total of 2 courses in the absence of disease
progression or unacceptable toxicity. Beginning 3 weeks after completion of chemotherapy,
male patients with CR or PR-1 receive radiotherapy 5 days per week to areas of initial
disease involvement (total duration of radiotherapy is dependent on initial extent of
disease). Consolidation for slow early responders: Patients with slow partial response
(PR-2) or stable disease (SD) after 4 courses of induction therapy receive 4 additional
courses of induction therapy in the absence of disease progression or unacceptable toxicity.
Beginning on day 8, patients receive G-CSF subcutaneously until blood counts recover.
Patients should be off G-CSF for more than 24 hours prior to the next course of
chemotherapy. Beginning 3 weeks after completion of chemotherapy, male and female patients
with PR-2 or SD receive radiotherapy 5 days per week to areas of initial disease involvement
(total duration of radiotherapy is dependent on initial extent of disease). Patients are
followed every 3 months for 2 years, every 6 months for 1 year, annually for 2 years and
then at years 10 and 20.

PROJECTED ACCRUAL: Approximately 25-50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven, previously untreated Hodgkin's disease
Stage IV OR Stage II or stage III with B symptoms (at least 1 of the following:
unexplained weight loss greater than 10%, unexplained recurrent fever greater than 39
degrees C, or drenching night sweats) AND bulk disease (defined as a mediastinal mass
greater than 1/3 of mediastinal thoracic diameter and/or nodal aggregate greater than 10.0
cm) The following cellular types are eligible: Mixed cellularity, not otherwise specified
(NOS) Lymphocytic depletion, NOS Lymphocytic depletion, diffuse fibrosis Lymphocytic
depletion, reticular Lymphocytic predominance, NOS Lymphocytic predominance, diffuse
Lymphocytic predominance, nodular Hodgkin's paragranuloma Hodgkin's granuloma Hodgkin's
sarcoma Nodular sclerosis, NOS Nodular sclerosis, cellular phase Nodular sclerosis,
lymphocytic predominance Nodular sclerosis, mixed cellularity Nodular sclerosis,
lymphocytic depletion Hodgkin's disease, NOS Must begin protocol therapy within 42 days of
biopsy and 7 days of completion of staging

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior treatment for Hodgkin's disease

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kara Kelly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067222

NCT ID:

NCT00004010

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • childhood lymphocyte predominant Hodgkin lymphoma
  • childhood lymphocyte depletion Hodgkin lymphoma
  • childhood nodular sclerosis Hodgkin lymphoma
  • childhood mixed cellularity Hodgkin lymphoma
  • 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
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-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
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 Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
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