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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 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:
- 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