Clinical trial NCT00352027
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Disease
Sponsor: St. Jude Children's Research Hospital
Start date: 2006-07-20; Completion date: 2022-11-15
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

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

Protocol documents: