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A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

Phase 2
18 Years
60 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging



- To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with
stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on
fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride,
bleomycin, vinblastine, and dacarbazine (ABVD).

- To estimate the 2-year PFS of patients who are PET-positive after treatment with 2
courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin
hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride,
and prednisone (BEACOPP).


- To estimate the 2-year overall survival (OS) of patients treated with these regimens.

- To estimate the response rate (i.e., complete and partial responses) in patients
treated with these regimens.

- To evaluate the toxicity of these response-adapted regimens.

- To document the feasibility of centralized, real-time review of FDG-PET imaging for
U.S. cooperative group studies.

- To prospectively evaluate the overall response rate, complete response rate, PFS, and
OS of HIV-positive patients treated with these response-adapted regimens.

OUTLINE: This is a multicenter study.

All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before
beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV,
vinblastine IV, and dacarbazine IV (ABVD) 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. Patients are stratified according to
FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with
ABVD for up to 4 additional courses in the absence of disease progression or unacceptable
toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV
positivity (yes or no) and receive 1 of the following treatment regimens:

- Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose
BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on
day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral
prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive
filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.

- Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP
chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1,
etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone
on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21
days for up to 6 courses in the absence of disease progression or unacceptable

Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment
FDG-PET/CT scan.

Some patients may undergo bone marrow biopsy at 1 month after the last course of

After completion of study treatment, patients are followed up periodically for 7 years.

Inclusion Criteria


- Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis,
mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)

- Previously untreated stage III or IV disease

- No nodular lymphocyte predominant disease

- Bidimensionally measurable disease

- Adequate biopsy samples from original diagnostic specimen must be available for
pathologic review

- Tissue obtained from core biopsies allowed

- No tissue obtained from needle aspirations or cytologies

- Must have known HIV status

- No multi-drug resistant HIV infection, CD4 counts < 150/μL, or other concurrent
AIDS-defining conditions in HIV-positive patients

- HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR
documented CD4 count > 250/μL at any time within 8 months prior to HL diagnosis

- Must have undergone unilateral or bilateral bone marrow biopsy within the past 42

- Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline
FDG-PET scan within the past 28 days

- Combined PET/CT scans required

- No older "stand-alone" FDG-PET scans

- No low-resolution "localization" CT scans as part of a combined PET/CT scans


- Zubrod performance status 0-2

- Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes
measured within the past 28 days

- Serum estradiol (women only), testosterone (men only), FSH and LH (both men and
women) levels must be drawn within 60 days prior to registration

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study therapy

- No significant cardiac abnormalities as assessed by MUGA scan or ECHO AND cardiac
ejection fraction ≥ 45% in patients with a history of hypertension or cardiac

- Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B
core antigen-negative)

- Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B
surface antibody-positive) are eligible

- Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)

- No significant lung disease with abnormal lung function tests (i.e., DLCO > 25% below
predicted after correction for hemoglobin) unless attributable to lymphoma

- No requirement for continuous supplemental oxygen therapy

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, adequately treated stage I or II cancer from which
the patient is currently in complete remission, or any other cancer from which the
patient has been disease-free for 5 years


- See Disease Characteristics

- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

- No prior solid organ transplantation

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year progression-free survival (PFS) of HIV-negative patients after treatment with 2 courses of ABVD

Safety Issue:


Principal Investigator

Oliver W. Press, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center



Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult nodular sclerosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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Community Hospital Munster, Indiana  46321
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Union Hospital of Cecil County Elkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Kaiser Permanente Medical Center - Anaheim/Orange County Anaheim, California  92805
Kaiser Permanente Medical Center - Baldwin Park Baldwin Park, California  91706
Kaiser Permanente Medical Center - Bellflower Bellflower, California  90706
Kaiser Permanente Medical Center - Fontana Fontana, California  92335
Kaiser Permanente Medical Center - Harbor City Harbor City, California  90710
Kaiser Foundation Hospital - West Los Angeles Los Angeles, California  90034
Kaiser Permanente Medical Center - Riverside Riverside, California  92505
Kaiser Permanente Medical Cener - Woodland Hills Woodland Hills, California  91365-4084
Sherman Hospital Elgin, Illinois  60120-2198
West Tennessee Cancer Center at Jackson-Madison County General Hospital Jackson, Tennessee  38301
Highlands Oncology Group - Springdale Springdale, Arkansas  72764
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
St. Charles Medical Center - Bend Bend, Oregon  97701
Galesburg Clinic, PC Galesburg, Illinois  61401
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Parvin Radiation Oncology Kansas City, Missouri  64116
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
Pacific Cancer Institute - Maui Wailuku, Hawaii  96793
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Mercy General Health Partners Muskegon, Michigan  49443
AnMed Cancer Center Anderson, South Carolina  29621
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Ochsner Health Center - Covington Covington, Louisiana  70433
Addison Gilbert Hospital Gloucester, Massachusetts  01930
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Falck Cancer Center at Arnot Ogden Medical Center Elmira, New York  14905
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115
Northwest Cancer Specialists at Vancouver Cancer Center Vancouver, Washington  98684
CCOP - Kansas City Prairie Village, Kansas  66208
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Central Dupage Cancer Center Warrenville, Illinois  60555
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Butler Memorial Hospital Butler, Pennsylvania  16001
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Northeast Georgia Cancer Care, LLC - Medical Oncology Athens, Georgia  30607
Highland Clinic Shreveport, Louisiana  71105
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Kaiser Permanente Health Care San Marcos, California  92069
Providence Regional Cancer Partnership Everett, Washington  98201
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688
St. Joseph Regional Medical Center Lewiston, Idaho  83501
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Kaiser Permanente - Irvine Irvine, California  92618
Ministry Saint Clare's Hospital Weston, Wisconsin  54476
Kaiser Permanente Fresno Medical Center Fresno, California  93720