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Sponsored by: |
St. Jude Children's Research Hospital |
Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00352027 |
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin's disease 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.
Condition | Intervention | Phase |
Hodgkin's Lymphoma |
Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin Procedure: Radiotherapy Drug: Etoposide, Nitrogen Mustard, Prednisone |
Phase II |
MedlinePlus related topics: | Cancer Hodgkin's Disease Lymphoma |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin's Disease |
Estimated Enrollment: | 82 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2017 |
Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1 |
Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin
See Detailed Description section for details of treatment interventions.
Procedure: Radiotherapy
See Detailed Description section for details of treatment interventions.
Drug: Etoposide, Nitrogen Mustard, Prednisone
See Detailed Description section for details of treatment interventions.
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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 6 mg/m2 IV Day 1 of weeks 1, 5, 9
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 sties will be based on response after 8 weeks of chemotherapy: 15 Gy for patients achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Monika Metzger, M.D. | 1-866-278-5833 | info@stjude.org |
United States, California | |||||
Stanford University Medical Center | Recruiting | ||||
Palo Alto, California, United States, 94304 | |||||
United States, Maine | |||||
Maine Children's Medical Center | Not yet recruiting | ||||
Portland, Maine, United States, 04102-3175 | |||||
United States, Massachusetts | |||||
Massachusetts General Hospital | Not yet recruiting | ||||
Boston, Massachusetts, United States, 02114 | |||||
Dana-Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
United States, Tennessee | |||||
St. Jude Children's Research Hospital | Recruiting | ||||
Memphis, Tennessee, United States, 38105 | |||||
Contact: Monika Metzger, M.D. 866-278-5833 info@stjude.org |
St. Jude Children's Research Hospital |
Principal Investigator: | Monika Metzger, M.D. | St. Jude Children's Research Hospital |
St. Jude Children's Research Hospital 
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Responsible Party: | St. Jude Children's Research Hospital ( Monika Metzger, Principal Investigator ) |
Study ID Numbers: | HOD05 |
First Received: | July 13, 2006 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00352027 |
Health Authority: | United States: Institutional Review Board |
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