S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/7/2017
Start Date:September 2011
End Date:March 2024

Use our guide to learn which trials are right for you!

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride,
vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by
killing the cells or by stopping them from dividing. Radiation therapy uses high-energy
x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer
growth in different ways. Some block the ability of cancer cells to grow and spread. Others
find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled
monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and
carry cancer-killing substances to them without harming normal cells. Comparing results of
diagnostic procedures, such as PET scan and CT scan, done before, during, and after
chemotherapy may help doctors predict a patient's response to treatment and help plan the
best treatment.

PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating
patients with limited-stage diffuse large B-cell lymphoma.

OBJECTIVES:

Primary

- To assess the 5-year progression-free survival (PFS) rate in patients with newly
diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission
tomography (PET)/CT scan to direct therapy after 3 courses of rituximab,
cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone
(R-CHOP).

Secondary

- To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients
with newly diagnosed limited-stage DLBCL.

- To evaluate toxicity of the protocol treatments in this patient population.

- To evaluate the response probability in this patient population.

- To evaluate overall survival in the overall population, and within the PET+ and PET-
subgroups.

- To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly
diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients
upstaged by PET/CT at baseline to advanced DLBCL.

- To describe outcomes in the subgroup of patients upstaged by PET/CT.

- To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs
stromal-2 gene expression signatures with PFS or overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to whether the
patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT
(yes vs no).

Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60
minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone
orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to
have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of
R-CHOP.

FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography
(FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of
course 3. Patients with complete response (PET scan negative) receive one additional course
of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field
radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.

Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y
90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.

Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow
tissue samples may be also collected for correlative studies.

After completion of study therapy, patients are followed up every 6 months for 2 years and
then yearly for 5 years.

DISEASE CHARACTERISTICS:

- Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)

- Adequate sections or a paraffin block from the original diagnostic specimen must
be submitted for review by the lymphoma pathology group

- Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20
antibodies or by immunoperoxidase staining of paraffin sections

- Patients with primary mediastinal lymphoma or testicular lymphoma are not
eligible

- Patients must have non-bulky stage I or II disease by Ann Arbor classification

- This staging excludes FDG-PET evaluation

- Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are
upstaged to stage III or IV based on FDG-PET evaluation, are also eligible

- Patients must have a diagnostic quality contrast-enhanced CT scan of the chest,
abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to
registration

- Low-resolution "localization" CT scans performed as part of a combined PET/CT
scan are not adequate for enrollment or response determination on this protocol

- If a patient has an allergy to CT contrast, then a non-enhanced CT will be
acceptable

- Patients must not have clinical evidence of central nervous system (CNS) involvement
by lymphoma

- Any laboratory or radiographic tests performed to assess CNS involvement must be
negative and must be performed within 42 days prior to registration

- Patients may have either measurable or evaluable limited-stage DLBCL

- Patients rendered free of measurable or evaluable disease by virtue of biopsy
(resection) are also eligible

- If patient has measurable disease it must be documented on the Lymphoma Baseline
Tumor Assessment Form (Form #15187)

- All measurable disease must be assessed within 28 days prior to registration

- Patients with non-measurable disease in addition to measurable disease must have
all non-measurable disease assessed within 42 days prior to registration

- Patients must have a unilateral or bilateral bone marrow biopsy performed within 42
days prior to registration

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Absolute neutrophil count (ANC) ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert syndrome)

- Patients must not be pregnant or nursing

- Women/men of reproductive potential must have agreed to use an effective contraceptive
method during the study period

- Patients must not be known to be HIV-positive

- No other prior malignancy is allowed except for the following:

- 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

- Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy
for lymphoma
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Duluth, MN
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
Phone: 218-786-3625
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Duluth, MN
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502 E 2nd St,
Duluth, Minnesota 55805
(218) 727-8762
Phone: 218-786-3625
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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Duluth, MN
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Phone: 612-625-3650
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Phone: 316-262-4467
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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El Dorado, KS
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
Phone: 303-399-8020
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Englewood, CO
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101 S Major St
Eureka, Illinois 61530
(309) 467-2371
Phone: 309-467-2371
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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Eureka, IL
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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Eureka, IL
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801 Broadway N
Fargo, North Dakota 58102
(701) 234-2000
Phone: 701-234-2397
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Fargo, ND
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
Phone: 701-234-2397
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Fargo, ND
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Fargo, North Dakota 58122
Phone: 701-234-2397
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Fargo, ND
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1255 Hwy 54 W,
Fayetteville, Georgia 30214
(770) 719-7000
Phone: 404-851-2340
Piedmont Fayette Hospital Piedmont Fayette Hospital, a 172-bed community hospital, is among the most highly-ranked...
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Fayetteville, GA
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Phone: 937-832-1093
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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Findlay, OH
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Phone: 810-762-8057
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Flint, MI
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Fort Scott, Kansas 66701
(620) 223-8589
Phone: 316-262-4467
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Fort Scott, KS
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105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
Phone: 937-832-1093
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Franklin, OH
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Phone: 612-884-6300
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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Fridley, MN
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3315 N. Seminary Street
Galesburg, Illinois 61401
(309) 344-1000
Phone: 309-344-1000
Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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Galesburg, IL
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