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Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

This study is currently recruiting participants.
Verified by St. Jude Children's Research Hospital, June 2008

Sponsored by: St. Jude Children's Research Hospital
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00352027
  Purpose

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin's disease who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin
Procedure: Radiotherapy
Drug: Etoposide, Nitrogen Mustard, Prednisone
Phase II

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Etoposide    Prednisone    Vincristine sulfate    Vincristine    Etoposide phosphate    Vinblastine    Vinblastine sulfate    Bleomycin    Bleomycin sulfate    Mechlorethamine    Mechlorethamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin's Disease

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Event free survival which is the time from treatment start to the time of the first failure (disease recurrence, second malignancy or death). [ Time Frame: 7-8 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   82
Study Start Date:   July 2006
Estimated Study Completion Date:   July 2017
Estimated Primary Completion Date:   July 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin
See Detailed Description section for details of treatment interventions.
Procedure: Radiotherapy
See Detailed Description section for details of treatment interventions.
Drug: Etoposide, Nitrogen Mustard, Prednisone
See Detailed Description section for details of treatment interventions.

Detailed Description:

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 6 mg/m2 IV Day 1 of weeks 1, 5, 9

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 sties will be based on response after 8 weeks of chemotherapy: 15 Gy for patients achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 extramedullary involvement, 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's disease.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352027

Contacts
Contact: Monika Metzger, M.D.     1-866-278-5833     info@stjude.org    

Locations
United States, California
Stanford University Medical Center     Recruiting
      Palo Alto, California, United States, 94304
United States, Maine
Maine Children's Medical Center     Not yet recruiting
      Portland, Maine, United States, 04102-3175
United States, Massachusetts
Massachusetts General Hospital     Not yet recruiting
      Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
United States, Tennessee
St. Jude Children's Research Hospital     Recruiting
      Memphis, Tennessee, United States, 38105
      Contact: Monika Metzger, M.D.     866-278-5833     info@stjude.org    

Sponsors and Collaborators
St. Jude Children's Research Hospital

Investigators
Principal Investigator:     Monika Metzger, M.D.     St. Jude Children's Research Hospital    
  More Information


St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site
 

Responsible Party:   St. Jude Children's Research Hospital ( Monika Metzger, Principal Investigator )
Study ID Numbers:   HOD05
First Received:   July 13, 2006
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00352027
Health Authority:   United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Hodgkin's Disease  

Study placed in the following topic categories:
Prednisone
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Vincristine
Vinblastine
Bleomycin
Etoposide phosphate
Doxorubicin
Lymphatic Diseases
Mechlorethamine
Hodgkin lymphoma, childhood
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Etoposide
Nitrogen Mustard Compounds

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 03, 2008




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