Overview

This trial is active, not recruiting.

Conditions childhood favorable prognosis hodgkin lymphoma, childhood lymphocyte depletion hodgkin lymphoma, childhood mixed cellularity hodgkin lymphoma, childhood nodular sclerosis hodgkin lymphoma, stage i childhood hodgkin lymphoma, stage ii childhood hodgkin lymphoma
Treatments radiation therapy, doxorubicin hydrochloride, vincristine sulfate, prednisone, cyclophosphamide, ifosfamide, vinorelbine tartrate, dexamethasone, etoposide phosphate, cisplatin, cytarabine, filgrastim
Phase phase 3
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2006
End date March 2012
Trial size 287 participants
Trial identifier NCT00302003, AHOD0431, CDR0000459962, COG-AHOD0431, NCI-2009-00377, U10CA098543

Summary

This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.
radiation therapy irradiation
Undergo radiation therapy
doxorubicin hydrochloride ADM
Given IV
vincristine sulfate leurocristine sulfate
Given IV
prednisone DeCortin
Given orally
cyclophosphamide CPM
Given IV
ifosfamide Cyfos
Given IV
vinorelbine tartrate Eunades
Given IV
dexamethasone Aeroseb-Dex
Given IV
etoposide phosphate ETOP
Given IV
cisplatin CACP
Given IV
cytarabine ARA-C
Given IV
filgrastim G-CSF
Given IV or subcutaneously

Primary Outcomes

Measure
Minimum time to a requirement for involved-field radiotherapy (IFRT), requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause
time frame: Up to 10 years
Minimum time to a relapse of higher risk at any time, any relapse following treatment with protocol-mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm
time frame: Up to 10 years
Minimum time to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm
time frame: Up to 10 years

Secondary Outcomes

Measure
Time to death
time frame: Up to 10 years

Eligibility Criteria

Male or female participants up to 21 years old.

Inclusion Criteria: - Histologically confirmed Hodgkin's lymphoma meeting the following criteria: - Newly diagnosed disease - Stage IA OR stage IIA without bulky disease - No lymphocyte-predominant histology - Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm - Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^3 - Total bilirubin =< 1.5 x normal - Alanine (ALT) =< 2.5 x normal - Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by multi-gated acquisition (MUGA) - No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG) - Female patients of childbearing potential must have a negative pregnancy test - Lactating females must agree that they will not breastfeed a child while on this study - Fertile patients must use effective contraception - Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Additional Information

Official title A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease
Principal investigator Frank Keller, MD
Description OBJECTIVES: I. Investigate the paradigm of response-based therapy for low-risk Hodgkin's lymphoma by eliminating involved-field radiotherapy (IFRT) in patients who achieve a complete remission (CR) after initial chemotherapy. II. Investigate whether 3 courses of doxorubicin hydrochloride, vincristine, prednisone, and cyclophosphamide (AV-PC) for the treatment of low-risk Hodgkin's lymphoma is sufficient to induce CR in at least 80% of patients. III. Investigate whether patients who experience a low-risk relapse after initial treatment with chemotherapy alone can be successfully treated with a salvage regimen comprising ifosfamide and vinorelbine ditartrate with dexamethasone, etoposide phosphate, cisplatin, and cytarabine (IV/DECA) and IFRT. IV. Maintain the overall survival for patients with low-risk Hodgkin's lymphoma at or above 97%. V. Determine the prognostic significance of very early response as measured by fludeoxyglucose-positron emission tomography (FDG-PET) or gallium after the first course of chemotherapy. VI. Evaluate the prognostic significance of elevation of erythrocyte sedimentation rate and C-reactive protein at the time of diagnosis in patients with low-risk Hodgkin's lymphoma on CR rate and relapse rate after chemotherapy alone. VII. Determine the frequency and severity of late effects of therapy, including thyroid dysfunction, infertility, cardiotoxicity, and second malignant neoplasms. OUTLINE: This is a multicenter study. INITIAL CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 10-30 minutes and cyclophosphamide IV over 1 hour on days 1-2, vincristine IV on days 1 and 8, prednisone orally (PO) on days 1-7, and filgrastim (G-CSF) subcutaneously (SC) on days 3-7 and 9-14. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) proceed to observation. Patients achieving partial remission proceed to radiotherapy. Patients who have a low-risk relapse after achieving CR on initial chemotherapy proceed to salvage chemotherapy followed by radiotherapy. Patients who have stable disease or disease progression go off study. SALVAGE CHEMOTHERAPY: Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1-5, and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients then receive dexamethasone IV over 15 minutes every 12 hours, etoposide phosphate IV over 3 hours every 12 hours, and cytarabine IV over 3 hours every 12 hours on days 1 and 2; cisplatin IV over 6 hours on day 1; and G-CSF SC or IV beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients then proceed to radiotherapy. INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning 4 weeks after completion of chemotherapy, patients undergo IFRT once daily, 5 days a week, for 2.8 weeks. Patients who do not achieve CR go off study. After completion of study treatment, patients are followed periodically for up to 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.