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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00678327
First received: May 9, 2008
Last updated: August 23, 2013
Last verified: June 2009
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-year progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678327

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   
Sponsors and Collaborators
Cancer Research UK
Investigators
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: August 23, 2013
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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Etoposide
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Bleomycin
Vinblastine
Procarbazine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014