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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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); filgrastim (Biological); pegfilgrastim (Biological); cyclophosphamide (Drug); dacarbazine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisolone (Drug); procarbazine hydrochloride (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cancer Research UK

Official(s) and/or principal investigator(s):
Peter Johnson, MD, Principal Investigator, Affiliation: University Hospital Southampton NHS Foundation Trust.

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.

Clinical Details

Official title: A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma

Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 3-year progression-free survival

Secondary outcome:

Overall survival

Acute and chronic toxicity as assessed by NCI CTCAE v3.0

Detailed description: OBJECTIVES:

- To determine if fludeoxyglucose F 18 (FDG)-PET/CT imaging can be reproducibly and

effectively applied in the early assessment of response to chemotherapy in patients with newly diagnosed stage II-IV Hodgkin lymphoma.

- To determine if a negative FDG-PET/CT scan after 2 courses of ABVD chemotherapy

comprising doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine can be used to predict a group of patients for whom it is safe to reduce therapy by the subsequent omission of bleomycin, without detriment to progression-free survival.

- To determine if treatment intensification in response to positive FDG-PET/CT imaging

after 2 courses of ABVD chemotherapy can improve the outcome by comparison with previous series. OUTLINE: This is a multicenter study. Patients undergo fludeoxyglucose F 18 (FDG)-PET/CT imaging at baseline. Patients then receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results.

- Negative FDG-PET/CT scan: Patients with a negative FDG-PET/CT scan are randomized to 1

of 2 treatment arms.

- Arm I (ABVD chemotherapy): Patients receive ABVD chemotherapy comprising

doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- Arm II (AVD chemotherapy): Patients receive AVD chemotherapy comprising

doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- Positive FDG-PET/CT scan: Patients with a positive FDG-PET/CT scan are assigned to 1 of

2 chemotherapy regimens, as determined by the participating center.

- BEACOPP-14 chemotherapy: Patients receive doxorubicin hydrochloride IV and

cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- BEACOPP-escalated chemotherapy: Patients receive doxorubicin hydrochloride IV and

cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of BEACOPP chemotherapy, patients undergo a third FDG-PET/CT scan to assess response. Patients with a negative FDG-PET/CT scan receive 2 more courses of BEACOPP-14 or 1 more course of BEACOPP-escalated chemotherapy. Patients with a persistently positive FDG-PET/CT scan may receive radiotherapy to sites of FDG uptake or salvage chemotherapy, at the investigator's discretion. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom; Recruiting
Peter Johnson, MD, Phone: 44-2380-796-186, Email: johnsonp@soton.ac.uk
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2008
Last updated: August 23, 2013

Page last updated: August 23, 2015

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