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Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Hodgkin Lymphoma

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Trial Information

Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma


Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of
weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5;
vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on
day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day for 8
weeks. Two to 3 weeks after all chemotherapy is given, patients not achieving a complete
response undergo radiation therapy to individual nodal sites (tailored fields).

PRIMARY OBJECTIVES:

1. To increase the complete response rate of favorable risk patients (excluding all patients
with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by
at least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine,
doxorubicin hydrochloride, methotrexate and prednisone (VAMP).

SECONDARY OBJECTIVES:

1. To estimate the disease failure rate within the radiation fields.

2. To examine patterns of treatment failure for children treated with low dose tailored
field radiation therapy.

3. 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 National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 3.0.

4. To compare the survival distributions (event-free and overall) and cumulative incidence
of local failure and toxicities of favorable risk patients treated with 8 weeks of
Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable
risk group of the HOD 99 study that received VAMP and low-dose involved-field
radiation.

5. To compare the survival distributions between patients that will not be prescribed
radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive
radiotherapy after VAMP.

6. To estimate the event-free survival distributions of favorable risk patients treated
with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy
plus low dose tailored field radiation.


Inclusion Criteria:



- Histologically confirmed, previously untreated Hodgkin lymphoma.

- Age: 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 disease (< 33% mediastinal to thoracic ratio on CXR)

- < 3 nodal regions involved on the same side of the diaphragm

- No "E" lesion

- Female patients who are post-menarchal must have a negative pregnancy test. Patients
of reproductive potential must agree to use an effective contraceptive method.

- Signed informed consent

- If re-evaluation of a patient's disease shows intermediate risk features, the patient
will be removed from the HOD08.

Exclusion Criteria:

- Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with
"E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients that will not require any radiotherapy by at least 20% more compared to the favorable risk arm in HOD99

Outcome Description:

A 95% confidence interval of the complete response (CR) rate will be provided.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Monika Metzger, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

HOD08

NCT ID:

NCT00846742

Start Date:

February 2009

Completion Date:

July 2026

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Maine Center for Cancer Medicine and Blood Disorders Scarborough, Maine  04074
Packard Children's Hospital, Stanford University Palo Alto, California  94304
Rady Children's Hospital- San Diego San Diego, California  92123
Dana-Farber Harvard Cancer Center Boston, Massachusetts  02115