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Health Condition(s) or Problem
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Lymphoma
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Lay Summary
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RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before,
during, and after chemotherapy may help doctors assess a patient's response to treatment and
help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in
assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it
works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage
III, or stage IV Hodgkin lymphoma.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following
criteria:
- Meets current WHO classification criteria (i.e., nodular sclerosis, mixed
cellularity, lymphocyte rich, and lymphocyte-depleted)
- Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with
adverse features, including any of the following:
- Bulk mediastinal disease, defined as maximal transverse diameter of mass >
0.33 of the internal thoracic diameter at D5/6 interspace on routine chest
x-ray
- Disease outside the mediastinum and lymph node or lymph node mass > 10 cm
in diameter
- More than two sites of disease
- Other poor-risk features that require treatment with full course
combination chemotherapy
- Newly diagnosed disease
- No CNS or meningeal involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy > 3 months
- ANC > 1,500/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Platelet count > 100,000/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Creatinine < 150% of upper limit of normal (ULN)
- Bilirubin < 2.0 times ULN (unless attributed to lymphoma)
- Transaminases < 2.5 times ULN (unless attributed to lymphoma)
- LVEF = 50% (in patients with a significant history of ischemic heart disease or
hypertension)
- Diffusion capacity within 25% of normal predicted value by lung function testing
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Amenable to the administration of a full course of chemotherapy, according to the
investigator
- Must have access to PET/CT scanning
- No poorly controlled diabetes mellitus
- No cardiac contraindication to doxorubicin hydrochloride, including abnormal
contractility by ECHO or MUGA
- No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy)
- No other concurrent uncontrolled medical condition
- No other active malignant disease within the past 10 years, except fully excised
basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine
cervix
- No known positivity for HIV, hepatitis B surface antigen, or hepatitis C
- Routine testing, in the absence of risk factors, is not required
- No medical or psychiatric condition that compromises the patient's ability to give
informed consent
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy or other investigational drug for HL
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- Histologically confirmed classical Hodgkin lymphoma (HL) meeting the following
criteria:
- Meets current WHO classification criteria (i.e., nodular sclerosis, mixed
cellularity, lymphocyte rich, and lymphocyte-depleted)
- Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with
adverse features, including any of the following:
- Bulk mediastinal disease, defined as maximal transverse diameter of mass >
0.33 of the internal thoracic diameter at D5/6 interspace on routine chest
x-ray
- Disease outside the mediastinum and lymph node or lymph node mass > 10 cm
in diameter
- More than two sites of disease
- Other poor-risk features that require treatment with full course
combination chemotherapy
- Newly diagnosed disease
- No CNS or meningeal involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy > 3 months
- ANC > 1,500/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Platelet count > 100,000/mm^3 (unless there is bone marrow infiltration by lymphoma)
- Creatinine < 150% of upper limit of normal (ULN)
- Bilirubin < 2.0 times ULN (unless attributed to lymphoma)
- Transaminases < 2.5 times ULN (unless attributed to lymphoma)
- LVEF = 50% (in patients with a significant history of ischemic heart disease or
hypertension)
- Diffusion capacity within 25% of normal predicted value by lung function testing
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Amenable to the administration of a full course of chemotherapy, according to the
investigator
- Must have access to PET/CT scanning
- No poorly controlled diabetes mellitus
- No cardiac contraindication to doxorubicin hydrochloride, including abnormal
contractility by ECHO or MUGA
- No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy)
- No other concurrent uncontrolled medical condition
- No other active malignant disease within the past 10 years, except fully excised
basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine
cervix
- No known positivity for HIV, hepatitis B surface antigen, or hepatitis C
- Routine testing, in the absence of risk factors, is not required
- No medical or psychiatric condition that compromises the patient's ability to give
informed consent
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy or other investigational drug for HL
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What will happen
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Biological; bleomycin sulfate; Given IV; Arm I; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Biological; filgrastim; Given subcutaneously; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Biological; pegfilgrastim; Given subcutaneously; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; cyclophosphamide; Given IV; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; dacarbazine; Given IV; Arm I; Arm II; Drug; doxorubicin hydrochloride; Given IV; Arm I; Arm II; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; etoposide; Given IV; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; prednisolone; Given orally; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; procarbazine hydrochloride; Given orally; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy; Drug; vinblastine sulfate; Given IV; Arm I; Arm II; Drug; vincristine sulfate; Given IV; BEACOPP-14 chemotherapy; BEACOPP-escalated chemotherapy
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Primary aim
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3-year progression-free survival
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Secondary Aim
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Overall survival; No; Acute and chronic toxicity as assessed by NCI CTCAE v3.0; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/CRUK-2007-006064-30
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Southampton
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