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 ClinicalTrials.gov)
DFCI Protocol ID: 10-327

 

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving chemotherapy together with radiation therapy may kill more cancer cells. Diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors plan the best treatment. PURPOSE: This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma.

 

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

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
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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