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Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [F] F.G.-PET Scanning


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [F] F.G.-PET Scanning


OBJECTIVES:

Primary

- Determine the 2-year progression-free survival (PFS) rate after treatment with
rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with bulky stage
II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma who remain positron
emission tomography (PET)-positive after 3 courses of rituximab, cyclophosphamide,
vincristine, doxorubicin hydrochloride, and prednisone.

Secondary

- Determine the proportion of mid-treatment PET-positive patients who become PET-negative
after 4 courses of R-ICE.

- Determine the PFS of mid-treatment PET-negative patients treated with these regimens.

- Determine the overall survival of patients treated with these regimens.

- Determine the toxicity of these regimens in these patients.

OUTLINE:

- Rituximab and CHOP chemotherapy (R-CHOP): Patients receive rituximab IV,
cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and
oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients undergo
fludeoxyglucose F18 positron emission tomography (PET) scanning and conventional
restaging during course 3. Based on the PET results, patients are assigned to 1 of 2
treatment groups.

- Group I (PET negative): Patients receive 2 more courses of R-CHOP as above in the
absence of disease progression or unacceptable toxicity.

- Group II (PET positive): Patients receive R-ICE comprising rituximab IV on day 1,
ifosfamide IV continuously over 24 hours and carboplatin IV over 30 minutes on day
2, and etoposide IV over 2 hours on days 1-3. Patients also receive filgrastim
(G-CSF) subcutaneously once daily starting on day 4 and continuing until blood
counts recover. Treatment repeats every 14 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years from
the date of study entry.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diffuse large B-cell non-Hodgkin's lymphoma

- Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease

- The following lymphoma types are excluded:

- Primary central nervous system lymphoma

- Transformed low-grade lymphoma (prior history of low-grade lymphoma or
clear presence of low-grade lymphoma on histologic sections)

- Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative
radiotherapy is usually indicated)

- Immunodeficiency-related lymphoma (i.e., after organ or bone marrow
transplant)

- Measurable disease

- Patient must have at least one objective measurable disease site (i.e.,
measurable in at least 2 perpendicular parameters)

- Measurable disease in the liver is required if the liver is the only site of
lymphoma involvement

- Abnormal positron emission tomography scans will not constitute evaluable
disease, unless verified by CT scan or other appropriate imaging

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- For patients > 50 years of age, a normal ejection fraction by ECHO or MUGA is
required within 6 weeks prior to registration

- Absolute neutrophil count ≥ 1,500/mm^3*

- Platelet count > 100,000/mm^3*

- Creatinine < 2.0 mg/dL*

- Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use an accepted and effective method of contraception

- No prior malignancy within the past 5 years unless it was in situ OR was treated with
curative intent AND the patient has remained relapse-free

- HIV negative NOTE: *Unless abnormal due to lymphoma

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiation therapy for lymphoma

- No prior anthracyclines or platinum compounds used as systemic chemotherapy

- No prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

- No concurrent pentostatin or trastuzumab (Herceptin®)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2- year progression-free survival (PFS)

Outcome Time Frame:

Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years.

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000455012

NCT ID:

NCT00274924

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Dean Medical Center - MadisonMadison, Wisconsin  53717
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Froedtert Hospital and Medical College of WisconsinMilwaukee, Wisconsin  53226-3596
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Hinsdale, Illinois  60521
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
SUNY Downstate Medical CenterBrooklyn, New York  11203
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Front Range Cancer SpecialistsFort Collins, Colorado  80528
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
McFarland Clinic, PCAmes, Iowa  50010
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Christ Hospital Cancer CenterCincinnati, Ohio  45219
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Galesburg Clinic, PCGalesburg, Illinois  61401
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096