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A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma


OBJECTIVES:

- To evaluate the response rate in patients with previously untreated stage II-IV
follicular non-Hodgkin lymphoma treated with rituximab, cyclophosphamide, doxorubicin
hydrochloride, vincristine sulfate, and prednisone (R-CHOP) in combination with iodine
I 131 tositumomab.

- To evaluate the toxicity of this regimen in these patients.

- To estimate the 3-year progression-free survival rate in patients treated with this
regimen.

- To estimate the 5-year progression-free and overall survival rate in patients treated
with this regimen.

- To assess the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive R-CHOP* comprising rituximab IV, cyclophosphamide
IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral
prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity. Patients with at least
stable disease then proceed to consolidation therapy.

NOTE: *Patients receive R-CHOP in courses 1-4 and CHOP alone in courses 5 and 6.

- Consolidation therapy: Within 12 weeks after completion of induction therapy, patients
receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131
tositumomab IV over 20 minutes. Patients then undergo whole body gamma camera scans
over a 1-week period to determine the rate of total body clearance of radioactivity and
the therapeutic dose of iodine I 131 tositumomab. Within 7-14 days after the dosimetric
dose, patients receive tositumomab IV over 1 hour followed by a therapeutic dose of
iodine I 131 tositumomab IV over 20 minutes. Patients with at least stable disease then
proceed to maintenance therapy.

- Maintenance therapy: Beginning approximately 1 year after study entry and no more than
28 days after restaging, patients receive rituximab IV every 3 months for up to 4 years
(16 courses) in the absence of disease progression or unacceptable toxicity.

After completion of maintenance therapy, patients are followed annually for up to 7 years.
Patients who do not complete maintenance therapy are followed every 6 months for 2 years and
then annually for up to 7 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma
meeting the following criteria:

- Bulky stage II or stage III or IV disease

- Diffuse large cell component must be < 25% of the biopsy

- Confirmed CD20 antigen-positive disease NOTE: *Needle aspiration or cytology are
not considered adequate for pathology review

- Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed
within 42 days

- Positive biopsy performed > 42 days but < 6 months allowed

- Previously untreated disease

- Bidimensionally measurable disease

- No clinical evidence of CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Cardiac ejection fraction ≥ 45% by MUGA or ECHO

- No significant cardiac abnormalities

- No known HIV positivity

- No requirement for continuous supplemental oxygen therapy

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer from which the patient is currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 12 months after
completion of maintenance therapy

PRIOR CONCURRENT THERAPY:

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

- No prior solid organ transplantation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year progression-free survival (PFS)

Outcome Description:

Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.

Outcome Time Frame:

0-3 years

Safety Issue:

No

Principal Investigator

Jonathan W. Friedberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000615104

NCT ID:

NCT00770224

Start Date:

September 2008

Completion Date:

December 2017

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Wesley Medical CenterWichita, Kansas  67214
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Crossroads Cancer CenterEffingham, Illinois  62401
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Clinton Memorial HospitalWilmington, Ohio  45177
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Mercy General Health PartnersMuskegon, Michigan  49443
AnMed Cancer CenterAnderson, South Carolina  29621
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905
Cancer Care Center of DecaturDecatur, Illinois  62526