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Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
Not Recruiting
Trial ID: NCT01390584
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)
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
Inclusion 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
Exclusion Criteria:
- 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
Intervention(s):
diagnostic test: PET
radiation: INRT
drug: Cyclophosphamide
drug: Vincristine
drug: Procarbazine
drug: Prednisone
drug: Doxorubicin
drug: Bleomycin
drug: Vinblastine
drug: Dacarbazine
drug: Etoposide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061