Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, 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 combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.
Official Title
Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)
Eligibility Criteria
- - Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008) - Patients must have clinical stage IA, IB, IIA, or IIB disease - Patients with "E" extensions will be eligible if all other criteria have been met - Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images - Bone marrow biopsy is required - ECOG performance status 0-2 - ANC ≥ 1,000/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 10 g/dL - Serum creatinine ≤ 2 mg/dL - Direct bilirubin ≤ 2 mg/dL - AST/ALT ≤ 2 times upper limit of normal - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception - LVEF by ECHO or MUGA normal unless thought to be disease related - DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related - Patients with a history of intravenous drug abuse, or any behavior associated with an increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol - HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on concurrent antiretrovirals - Patient HIV status must be known prior to registration - HIV-positive patients must not have multi-drug resistant HIV infections; CD4 counts < 400/mm³; or other concurrent AIDS-defining conditions - Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed
- - Nodular lymphocyte-predominant Hodgkin lymphoma - Pregnant or nursing - "Currently active" second malignancy other than non-melanoma skin cancers - Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse - Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
