NCT00352027

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Adriamycin®	Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.
DRUG	Vinblastine	Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.
DRUG	Nitrogen Mustard	Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.
DRUG	Cyclophosphamide	May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.
DRUG	Vincristine	Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
DRUG	Bleomycin	Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.
DRUG	Etoposide	Given IV on Days 1 and 2 of weeks 1-10.
DRUG	Prednisone	Given PO every other day of weeks 1-12.
BIOLOGICAL	G-CSF	Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).
PROCEDURE	Radiotherapy	Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.

Timeline

• Start date: 2006-07-20
• Primary completion: 2015-05-01
• Completion: 2022-11-15
• First posted: 2006-07-14
• Last updated: 2023-09-22
• Results posted: 2016-10-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study