Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma

Trial ID or NCT#

NCT01920932

Status

not recruiting iconNOT RECRUITING

Purpose

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Official Title

Adcetris (Brentuximab Vedotin), Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High Risk Pediatric Hodgkin Lymphoma (HL)

Eligibility Criteria

Ages Eligible for Study: Younger than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment). - Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday). - Ann Arbor stage IIB, IIIB, IVA, or IVB. - Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender. - Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age). - Female participant who is post-menarchal must have a negative urine or serum pregnancy test. - Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Exclusion Criteria:
  1. - CD30 negative HL. - Has received prior therapy for Hodgkin lymphoma, except as noted above. - Inadequate organ function as described above. - Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
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Investigator(s)

Michael Link
Sarah S. Donaldson, MD

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov