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Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Hodgkin's Lymphoma
NCT ID: NCT01118026 (View complete trial on
DFCI Protocol ID: 10-327


This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with use of radiation used in current treatments. The chemotherapy treatment in this study consists of a combination of four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been found to be effective in treating patients with Hodgkin lymphoma and is considered the standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET scans will be obtained during the course of therapy. The usefulness of this PET scan will be evaluated to determine whether radiation may be left out in the treatment of disease if the PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify a group of patients using early PET scans in order to change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has become standard of care in Europe, its use has been more limited in the U.S. because of concerns about toxicity.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Ann LaCasce, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jeremy Abramson, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Kathleen McDermott,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed* Hodgkin lymphoma - Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system - Subclassified according to the WHO modification of the Rye Classification - Patients with "E" extensions are eligible provided all other criteria have been met NOTE: *Patients must submit pathology materials within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates are not acceptable. If multiple specimens are available, submit the most recent. - No nodular lymphocyte-predominant Hodgkin lymphoma - Has a mediastinal mass > 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter - Has undergone a bone marrow biopsy for pretreatment evaluation PATIENT CHARACTERISTICS: - Performance status 0-2 - ANC ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Serum creatinine ≤ 2 mg/dL - Bilirubin ≤ 2 times upper limit of normal (ULN) (in the absence of Gilbert disease) - AST ≤ 2 times ULN - 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) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No "currently active" second malignancy other than nonmelanoma 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 < 30% risk of relapse - Patients with known HIV are eligible provided their CD4 count is > 350, and they are on concurrent antiretrovirals - An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIV PRIOR CONCURRENT THERAPY: - No prior treatment (chemotherapy or radiotherapy) for Hodgkin lymphoma - No concurrent zidovudine or stavudine as part of the antiretroviral therapy for HIV-positive patients - No concurrent hormones or other chemotherapeutic agents, except for the following: - Steroids for adrenal failure - Hormones for non-disease-related conditions (e.g., insulin for diabetes) - Dexamethasone on the day of chemotherapy for (acute) chemotherapy-induced nausea or vomiting - No concurrent intensity-modulated radiation therapy or cobalt-60
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