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Risk-Adapted Therapy for Pediatric Hodgkin''s Disease - Article


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Mechlorethamine

Mustargen



Clinical Trial: Risk-Adapted Therapy for Pediatric Hodgkin''s Disease

Risk-Adapted Therapy for Pediatric Hodgkin’s Disease

This study is currently recruiting patients.
Verified by St. Jude Children''''s Research Hospital September 2005

Sponsors and Collaborators: St. Jude Children''''s Research Hospital
Maine Children''''s Cancer Program
Massachusetts General Hospital
Stanford University
Dana-Farber Cancer Institute
Information provided by: St. Jude Children''''s Research Hospital
ClinicalTrials.gov Identifier: NCT00145600

Purpose

Hodgkin’s disease is a cancer of the lymphatic system, a network of thin vessels and glands located all over the body. The system is involved in fighting infection. Survival rates for children with Hodgkin’s disease have improved greatly in the past 25–30 years. Most patients who receive treatment will have a long-term remission (disease-free state). However, some side effects of treatment can occur more than 10 years after treatment (late effects). They can include heart, lung, and thyroid problems; sterility (inability to have children); and second cancers.

Researchers are studying ways to maintain current survival rates and to reduce late effects of therapy. In the past, treatment for Hodgkin’s disease included high doses of anti-cancer fighting drugs. Some caused patients to become sterile, to develop leukemia, or to develop heart problems. Past treatments also used higher doses of radiation therapy. In some cases, the radiation caused growth problems in patients. It also put them at higher risk for heart disease and second cancers as they aged. This study will test whether new combinations of drugs can decrease the long-term side effects. The study will also test lower doses of radiation therapy. Study subjects will be assigned to treatment based on several risk factors which can affect how well each subject responds to treatment. The risk group is decided on the basis of how large or “bulky” the lymph glands have grown, how much the cancer has spread (stage), and whether symptoms like fever, sweat, or weight loss are present. In this study, patients will be placed in one of three risk groups. Lower doses of chemotherapy and radiation therapy will be given to patients in the lower risk groups.

Condition Intervention Phase
Hodgkin’s Disease
 Drug: Vinblastine
 Drug: Doxorubicin
 Drug: Methotrexate
 Drug: Prednisone
 Drug: Vincristine
 Drug: Mechlorethamine Hydrochloride
 Drug: Bleomycin
 Drug: Etoposide
 Drug: Filgrastim
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: To find out if patients with Hodgkin’s disease can be effectively treated with fewer chemotherapy treatments and lower doses of radiation.
Secondary Outcomes: To study patients’ quality of life during and after treatment.
Expected Total Enrollment:  170

Study start: March 2000

Eligibility

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Histologically confirmed, previously untreated Hodgkin’s disease (Patients receiving limited emergent radiation therapy or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
  • Age: 21 years of age or younger
  • Stage: Ann Arbor stages
  • No prior treatment
  • No pregnant or nursing women

Exclusion Criteria:

  • Pregnant or nursing women

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145600

Melissa M Hudson, MD      866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Melissa M Hudson, MD  866-278-5833    info@stjude.org 
Melissa M Hudson, MD,  Principal Investigator

Study chairs or principal investigators

Melissa M Hudson, MD,  Principal Investigator,  St. Jude Children''''s Research Hospital   

More Information

St. Jude Children''''s Research Hospital

Study ID Numbers:  HOD99
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145600
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06

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Page Updated: June 1, 2005
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