Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease
Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: bleomycin sulfate (Biological); filgrastim (Biological); ABVD regimen (Drug); cyclophosphamide (Drug); dacarbazine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Oncology Group Official(s) and/or principal investigator(s): Kara Kelly, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy
after chemotherapy may be an effective treatment for Hodgkin's disease.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation
therapy in treating children who have previously untreated stage II, stage III, or stage IV
Hodgkin's disease.
Clinical Details
Official title: Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Estimate the rate of BEACOPP )((Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) specific toxicity in pediatric patients
Secondary outcome: Obtain preliminary estimates of response to BEACOPP ((Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
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
Locations and Contacts
British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada
Long Beach Memorial Medical Center, Long Beach, California 90806, United States
Children's Hospital Los Angeles, Los Angeles, California 90027-0700, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States
Children's Hospital of Orange County, Orange, California 92868, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States
David Grant Medical Center, Travis Air Force Base, California 94535, United States
Children's Hospital of Denver, Denver, Colorado 80218, United States
Children's National Medical Center, Washington, District of Columbia 20010-2970, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States
Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Children's Mercy Hospital, Kansas City, Missouri 64108, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey 07503, United States
Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States
IWK Health Centre, Halifax, Nova Scotia B3J 3G9, Canada
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States
Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States
Children's Hospital of Columbus, Columbus, Ohio 43205-2696, United States
Doernbecher Children's Hospital, Portland, Oregon 97201-3098, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States
Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1999
Last updated: February 25, 2014
|