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Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma


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

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Trial Information

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma


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.


Inclusion Criteria:



- Patient is less than or equal to 21 years of age

- Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma

- Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal
involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

- Patients with favorable risk features

- Patients with unfavorable risk features

- Patients who have received prior therapy for Hodgkin lymphoma.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event free survival

Outcome Description:

the time from treatment start to the time of the first failure (disease recurrence, second malignancy or death)

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Monika Metzger, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

HOD05

NCT ID:

NCT00352027

Start Date:

July 2006

Completion Date:

November 2022

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Rady Children's Hospital San DiegoSan Diego, California  92123
Maine Children's Medical CenterPortland, Maine  04102-3175