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S0816 Fludeoxyglucose F 18-PE...

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

Last Updated: 2022-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2022-06-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.

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Detailed Description

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OBJECTIVES:

Primary

* 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).

Secondary

* 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 toxicity.

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 chemotherapy.

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

Conditions

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Lymphoma Nonneoplastic Condition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV Positive, PET Positive: BEACOPP standard

Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles

Group Type EXPERIMENTAL

bleomycin sulfate

Intervention Type BIOLOGICAL

BEACOPP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

prednisone

Intervention Type DRUG

procarbazine hydrochloride

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

HIV Negative, PET Positive: BEACOPP escalated

Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles

Group Type EXPERIMENTAL

bleomycin sulfate

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

BEACOPP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

prednisone

Intervention Type DRUG

procarbazine hydrochloride

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

HIV Positive, PET Negative: ABVD

Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2

Group Type ACTIVE_COMPARATOR

bleomycin sulfate

Intervention Type BIOLOGICAL

ABVD regimen

Intervention Type DRUG

dacarbazine

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

HIV Negative, PET Negative: ABVD

Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2

Group Type ACTIVE_COMPARATOR

bleomycin sulfate

Intervention Type BIOLOGICAL

ABVD regimen

Intervention Type DRUG

dacarbazine

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

Interventions

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bleomycin sulfate

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

ABVD regimen

Intervention Type DRUG

BEACOPP regimen

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

dacarbazine

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

prednisone

Intervention Type DRUG

procarbazine hydrochloride

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
* No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (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

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
* No prior solid organ transplantation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver W. Press, MD, PhD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

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Arizona Cancer Center at University Medical Center North

Tucson, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group - Springdale

Rogers, Arkansas, United States

Site Status

Kaiser Permanente Medical Center - Anaheim/Orange County

Anaheim, California, United States

Site Status

Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

Kaiser Permanente Medical Center - Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente Medical Center - Bellflower

Bellflower, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente Medical Center - Fontana

Fontana, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Kaiser Permanente Fresno Medical Center

Fresno, California, United States

Site Status

Kaiser Permanente Medical Center - Harbor City

Harbor City, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Kaiser Permanente - Irvine

Irvine, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, United States

Site Status

Kaiser Foundation Hospital - West Los Angeles

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

Kaiser Permanente Medical Group

Panorama City, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Riverside

Riverside, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

San Diego, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Permanente Health Care

San Marcos, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

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Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

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Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

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Kaiser Permanente Medical Cener - Woodland Hills

Woodland Hills, California, United States

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Aurora Presbyterian Hospital

Aurora, Colorado, United States

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Boulder Community Hospital

Boulder, Colorado, United States

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Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

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Kaiser Permanente - Denver

Denver, Colorado, United States

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Porter Adventist Hospital

Denver, Colorado, United States

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Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

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St. Joseph Hospital

Denver, Colorado, United States

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Rose Medical Center

Denver, Colorado, United States

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CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

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St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

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Kaiser Permanente - Lafayette

Lafayette, Colorado, United States

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Littleton Adventist Hospital

Littleton, Colorado, United States

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Sky Ridge Medical Center

Lone Tree, Colorado, United States

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Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

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McKee Medical Center

Loveland, Colorado, United States

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Parker Adventist Hospital

Parker, Colorado, United States

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St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

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North Suburban Medical Center

Thornton, Colorado, United States

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Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

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Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

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Manchester Memorial Hospital

Manchester, Connecticut, United States

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Yale Cancer Center

New Haven, Connecticut, United States

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Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

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CCOP - Christiana Care Health Services

Newark, Delaware, United States

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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Site Status

Northeast Georgia Cancer Care, LLC - Medical Oncology

Athens, Georgia, United States

Site Status

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status