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
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Biological: pegfilgrastim Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma |
- 3-year progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Acute and chronic toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
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.
|
Biological: bleomycin sulfate
Given IV
Drug: dacarbazine
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vinblastine sulfate
Given IV
|
|
Active Comparator: Arm II
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.
|
Drug: dacarbazine
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vinblastine sulfate
Given IV
|
|
Experimental: 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.
|
Biological: bleomycin sulfate
Given IV
Biological: filgrastim
Given subcutaneously
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: prednisolone
Given orally
Drug: procarbazine hydrochloride
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: 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.
|
Biological: bleomycin sulfate
Given IV
Biological: filgrastim
Given subcutaneously
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: prednisolone
Given orally
Drug: procarbazine hydrochloride
Given orally
Drug: vincristine sulfate
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Peter Johnson, MD 44-2380-796-186 johnsonp@soton.ac.uk | |
| Principal Investigator: | Peter Johnson, MD | University Hospital Southampton NHS Foundation Trust. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00678327 History of Changes |
| Other Study ID Numbers: | CDR0000593562, CRUK-2007-006064-30, CRUK-07/146 |
| Study First Received: | May 9, 2008 |
| Last Updated: | November 2, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Etoposide phosphate Cyclophosphamide Dacarbazine Etoposide Prednisolone |
Methylprednisolone Hemisuccinate Procarbazine Vinblastine Vincristine Lenograstim Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 17, 2013