NCT00145600

Therapy for Pediatric Hodgkin Lymphoma

Risk-Adapted Therapy for Pediatric Hodgkin's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

Detailed description

This study will evaluate the following objectives: Primary Objectives: 1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP chemotherapy. 2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of VAMP chemotherapy. 3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate risk Hodgkin's disease. 4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children with unfavorable risk Hodgkin's disease. Secondary Objectives: 1. To evaluate patient quality of life during and after treatment from the patient and parent perspective. 2. To compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response); after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation (as applicable) (T3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (T4); and at 3 to 6 months after completion of therapy follow-up evaluation (T5).

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	12 Week Stanford V Chemotherapy	12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children
DRUG	4 cycles of VAMP chemotherapy	4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.
DRUG	2 alternating cycles of VAMP/COP chemotherapy	2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.
DRUG	3 alternating cycles of VAMP/COP chemotherapy	3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT

Timeline

• Start date: 2000-03-02
• Primary completion: 2012-05-31
• Completion: 2021-11-05
• First posted: 2005-09-05
• Last updated: 2022-10-20
• Results posted: 2013-05-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study