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
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
Secondary Outcomes: To study patients’ quality of life during and after treatment.
Expected Total Enrollment: 170
Study start: March 2000
Eligibility
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
Tennessee
St. Jude Children''''s Research Hospital, Memphis, Tennessee, 38105, United States; Recruiting
Melissa M Hudson, MD, Principal Investigator
Melissa M Hudson, MD, Principal Investigator, St. Jude Children''''s Research Hospital
More Information
St. Jude Children''''s Research Hospital
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
Resources
- Mechlorethamine (Drug Digest)
- Mustargen (Drug Digest)

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