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

Not Recruiting

Trial ID: NCT01920932

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)

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - 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 enrollment (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:

   - 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.

Intervention(s):

other: quality of life assessment

drug: brentuximab vedotin

drug: etoposide

drug: prednisone

drug: doxorubicin

drug: cyclophosphamide

drug: Dacarbazine(R)

drug: filgrastim

radiation: radiation therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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