Overview

This trial is active, not recruiting.

Condition hodgkin's lymphoma
Treatments adriamycin, vinblastine, vincristine, bleomycin, etoposide, nitrogen mustard (cyclophosphamide), prednisone, radiotherapy, etoposide, nitrogen mustard (cyclophosphamide) , vincristine, vinblastine, adriamycin, bleomycin, prednisone
Phase phase 2
Sponsor St. Jude Children's Research Hospital
Start date July 2006
End date May 2015
Trial size 82 participants
Trial identifier NCT00352027, HOD05

Summary

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adriamycin, vinblastine, vincristine, bleomycin, etoposide, nitrogen mustard (cyclophosphamide), prednisone
See Detailed Description section for details of treatment interventions.
radiotherapy
See Detailed Description section for details of treatment interventions.
etoposide, nitrogen mustard (cyclophosphamide) , vincristine, vinblastine, adriamycin, bleomycin, prednisone
See Detailed Description section for details of treatment interventions.

Primary Outcomes

Measure
Event free survival
time frame: 3 years

Secondary Outcomes

Measure
Disease failure rate within radiation fields
time frame: 3 years
Treatment failure patterns for children treated with tailored-field radiation
time frame: 3 years follow-up
Prognostic factors for treatment failure
time frame: 3 years follow-up
Describe toxicities, particularly the frequency and severity of late effects of therapy
time frame: 1, 2, 5, and 10 years post therapy
Patient quality of life (QoL)
time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Parent proxy quality of life (QoL)
time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation of agreement between patient QoL and parent proxy QoL at multiple time points
time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Symptom distress
time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Correlation between QoL and symptom distress
time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
Comparison of the survival distributions and toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99 and other combined modality regimens
time frame: 3 years

Eligibility Criteria

Male or female participants up to 21 years old.

Inclusion Criteria: - Patient is less than or equal to 21 years of age - Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma - Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy. Exclusion Criteria: - Patients with favorable risk features - Patients with unfavorable risk features - Patients who have received prior therapy for Hodgkin lymphoma.

Additional Information

Official title Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
Principal investigator Monika Metzger, M.D.
Description Treatment Plan Description: Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11 Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9 Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage) Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11 Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12 G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated) * Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by St. Jude Children's Research Hospital.