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Risk-Adapted Therapy for Pediatric Hodgkin's Disease


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

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Trial Information

Risk-Adapted Therapy for Pediatric Hodgkin's Disease


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).

Inclusion Criteria


General Eligibility Criteria:

1. Eligible patients must have histologically confirmed previously untreated Hodgkin's
disease (Patients receiving limited emergent RT or steroid therapy because of
cardiopulmonary decompensation or spinal cord compression will be eligible for
protocol enrollment).

2. Patients must be 21 years of age or younger

3. Ann Arbor stages IIB-IV

4. No prior treatment.

5. No pregnant or lactating women.

6. Signed informed consent

7. If re-evaluation of a patient's disease shows favorable risk features or intermediate
risk features, the patient will be removed from the HOD99 study and consented to the
respective HOD08 or HOD05 study.

Eligibility for treatment of favorable risk features:

1. Ann Arbor stage IA or IIA with:

1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)

2. < 3 nodal regions involved on the same side of the diaphragm

3. No "E" lesion

Eligibility for treatment of intermediate risk features:

1. Stage must be classified as one of the following:

1. Ann Arbor stage IB and IIIA

2. Ann Arbor stage IA or IIA with ANY of the following features: (1) "E" lesion(s), (2)
3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to
thoracic cavity ratio 33% or greater by chest radiograph)

Eligibility of unfavorable risk features:

1. Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free Survival Probability by Risk Group

Outcome Description:

Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.

Outcome Time Frame:

Median 6.4 year follow-up

Safety Issue:

No

Principal Investigator

Monika Metzger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

HOD99

NCT ID:

NCT00145600

Start Date:

March 2000

Completion Date:

June 2013

Related Keywords:

  • Hodgkin Lymphoma
  • Lymphoma
  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford UniversityStanford, California  94305
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115