Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK; University College, London
• Collaborators: Cancer Research UK; Cancer Research UK & UCL Cancer Trials Centre
• Treatments: Bleomycin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Lenograstim; Liposomal doxorubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Procarbazine; Vinblastine; Vincristine

Criteria

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