Protocol

HOD08: Reduced duration Stanford V Chemotherapy with low-dost tailored-field radiation therapy for favorable risk pediatric Hodgkin lymphoma

Diseases

Leukemias / Lymphomas : Hodgkin lymphoma

Description

This phase II study is being done to increase the proportion of patients that will not require radiation therapy while maintaining the same cure rate, therefore reducing radiation associated long term side effects. The study will review how many research participants have a complete response after 8 weeks of Stanford V chemotherapy and therefore not require radiation therapy, compared to treatments that have been given in the past.  The study will also collect information about all the effects (good and bad) of treatment with Stanford V chemotherapy alone, and with Stanford V chemotherapy plus low-dose tailored-field radiation therapy.

Patients will be treated with 8 weeks of Stanford V chemotherapy. Radiation therapy will be omitted for patients achieving a complete response after 8 weeks of chemotherapy. Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following  completion of all chemotherapy and recovery of ANC to at least 1000.


Objectives

  • To increase the complete response rate after 8 weeks Stanford V by at least 20% compared to patients on HOD 99 after 8 weeks VAMP
  • To estimate the disease failure rate within the radiation fields.
  • To examine patterns of treatment failure for children treated with low dose tailored field radiation therapy.
  • To describe acute hematologic and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE),

Eligibility

  • Histologically confirmed, previously untreated Hodgkin lymphoma
  • Participants must be 21 years of age or younger
  • Stage must be classified as one of the following:
    • Ann Arbor stage IA or IIA with:
      • Non-bulky mediastinal mass (< 33% mediastinal to thoracic ratio)
      • < 3 nodal regions involved on the same side of the diaphragm
      • No “E” lesion (extranodal extension)

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).


Contact

Monika Metzger, MD, MSc
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice:   1-866-2ST-JUDE  (1-866-278-5833)
FAX:     901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

Initial Version dated 12.24.08, IRB approved 2.10.09


The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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