S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
Overview[ - collapse ][ - ]
| Purpose | RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. |
|---|---|
| Condition | Lymphoma |
| Intervention | Biological: rituximab Biological: tositumomab Drug: cyclophosphamide Drug: doxorubicin Drug: prednisone Drug: vincristine Radiation: tositumomab |
| Phase | Phase 2 |
| Sponsor | Southwest Oncology Group |
| Responsible Party | Southwest Oncology Group |
| ClinicalTrials.gov Identifier | NCT00770224 |
| First Received | October 8, 2008 |
| Last Updated | June 12, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 8, 2008 |
|---|---|
| Last Updated Date | June 12, 2013 |
| Start Date | September 2008 |
| Estimated Primary Completion Date | December 2017 |
| Current Primary Outcome Measures | 3-year progression-free survival (PFS) [Time Frame: 0-3 years] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma |
|---|---|
| Official Title | 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 |
| Brief Summary | RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. |
| Detailed Description | 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Biological: rituximab Biological: tositumomab Drug: cyclophosphamide Drug: doxorubicin Drug: prednisone Drug: vincristine Radiation: tositumomab Other Names: iodine I 131 tositumomab |
| Study Arm (s) | Experimental: R-CHOP, tositumomab and rituximab Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody. Rituximab 375 mg/m2 IV q 3 months x 4 years beginning 1 year after registration. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 80 |
| Estimated Completion Date | December 2017 |
| Estimated Primary Completion Date | June 2014 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00770224 |
|---|---|
| Other Study ID Numbers | CDR0000615104 |
| Has Data Monitoring Committee | No |
| Information Provided By | Southwest Oncology Group |
| Study Sponsor | Southwest Oncology Group |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Jonathan W. Friedberg, MD James P. Wilmot Cancer CenterStudy Chair: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research CenterStudy Chair: Lisa Rimsza, MD University of Arizona |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| Providence Cancer Center at Providence Hospital | Mobile, Alabama, United States, 36608 |
|---|---|
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona, United States, 85724-5024 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois, United States, 62002 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois, United States, 62526 |
| Cancer Care Center of Decatur | Decatur, Illinois, United States, 62526 |
| Crossroads Cancer Center | Effingham, Illinois, United States, 62401 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois, United States, 60153 |
| Good Samaritan Regional Health Center | Mount Vernon, Illinois, United States, 62864 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois, United States, 62781-0001 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana, United States, 46107 |
| Reid Hospital & Health Care Services | Richmond, Indiana, United States, 47374 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas, United States, 66720 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas, United States, 67801 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas, United States, 67042 |
| Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas, United States, 66701 |
| Cancer Center of Kansas-Independence | Independence, Kansas, United States, 67301 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas, United States, 67068 |
| Lawrence Memorial Hospital | Lawrence, Kansas, United States, 66044 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas, United States, 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas, United States, 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas, United States, 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas, United States, 67401 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas, United States, 67401 |
| Cotton-O'Neil Cancer Center | Topeka, Kansas, United States, 66606 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas, United States, 67152 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas, United States, 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas, United States, 67208 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas, United States, 67214 |
| CCOP - Wichita | Wichita, Kansas, United States, 67214 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas, United States, 67214 |
| Wesley Medical Center | Wichita, Kansas, United States, 67214 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas, United States, 67156 |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland, United States, 21215 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan, United States, 49017 |
| Mecosta County Medical Center | Big Rapids, Michigan, United States, 49307 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan, United States, 49503 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan, United States, 49503 |
| CCOP - Grand Rapids | Grand Rapids, Michigan, United States, 49503 |
| Mercy General Health Partners | Muskegon, Michigan, United States, 49443 |
| Munson Medical Center | Traverse City, Michigan, United States, 49684 |
| Metro Health Hospital | Wyoming, Michigan, United States, 49519 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi, United States, 39216 |
| Saint Francis Medical Center | Cape Girardeau, Missouri, United States, 63703 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri, United States, 63141 |
| David C. Pratt Cancer Center at St. John's Mercy | Saint Louis, Missouri, United States, 63141 |
| Midwest Hematology Oncology Group, Incorporated | Saint Louis, Missouri, United States, 63109 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana, United States, 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana, United States, 59102 |
| CCOP - Montana Cancer Consortium | Billings, Montana, United States, 59101 |
| Billings Clinic - Downtown | Billings, Montana, United States, 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana, United States, 59715 |
| St. James Healthcare Cancer Care | Butte, Montana, United States, 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana, United States, 59405 |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana, United States, 59405 |
| Northern Montana Hospital | Havre, Montana, United States, 59501 |
| St. Peter's Hospital | Helena, Montana, United States, 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana, United States, 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana, United States, 59901 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana, United States, 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana, United States, 59807 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana, United States, 59807-7877 |
| Falck Cancer Center at Arnot Ogden Medical Center | Elmira, New York, United States, 14905 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York, United States, 14642 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina, United States, 27534 |
| Rutherford Hospital | Rutherfordton, North Carolina, United States, 28139 |
| Mary Rutan Hospital | Bellefontaine, Ohio, United States, 43311 |
| Adena Regional Medical Center | Chillicothe, Ohio, United States, 45601 |
| CCOP - Columbus | Columbus, Ohio, United States, 43215 |
| Mount Carmel Health - West Hospital | Columbus, Ohio, United States, 43222 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio, United States, 43214-3998 |
| Doctors Hospital at Ohio Health | Columbus, Ohio, United States, 43228 |
| Grant Medical Center Cancer Care | Columbus, Ohio, United States, 43215 |
| CCOP - Dayton | Dayton, Ohio, United States, 45420 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio, United States, 45409 |
| Samaritan North Cancer Care Center | Dayton, Ohio, United States, 45415 |
| Grandview Hospital | Dayton, Ohio, United States, 45405 |
| Good Samaritan Hospital | Dayton, Ohio, United States, 45406 |
| Grady Memorial Hospital | Delaware, Ohio, United States, 43015 |
| Blanchard Valley Medical Associates | Findlay, Ohio, United States, 45840 |
| Middletown Regional Hospital | Franklin, Ohio, United States, 45005-1066 |
| Wayne Hospital | Greenville, Ohio, United States, 45331 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio, United States, 45429 |
| Fairfield Medical Center | Lancaster, Ohio, United States, 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio, United States, 45750 |
| Knox Community Hospital | Mount Vernon, Ohio, United States, 43050 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio, United States, 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio, United States, 45505 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio, United States, 45373-1300 |
| Mount Carmel St. Ann's Cancer Center | Westerville, Ohio, United States, 43081 |
| Clinton Memorial Hospital | Wilmington, Ohio, United States, 45177 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio, United States, 45385 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio, United States, 43701 |
| AnMed Cancer Center | Anderson, South Carolina, United States, 29621 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina, United States, 29303 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina, United States, 29303 |
| U.T. Medical Center Cancer Institute | Knoxville, Tennessee, United States, 37920-6999 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah, United States, 84112 |
| St. Joseph Cancer Center | Bellingham, Washington, United States, 98225 |
| Olympic Hematology and Oncology | Bremerton, Washington, United States, 98310 |
| Columbia Basin Hematology | Kennewick, Washington, United States, 99336 |
| Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington, United States, 98273 |
| Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington, United States, 98370 |
| Harborview Medical Center | Seattle, Washington, United States, 98104 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington, United States, 98122-4307 |
| Minor and James Medical, PLLC | Seattle, Washington, United States, 98104 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington, United States, 98109 |
| Group Health Central Hospital | Seattle, Washington, United States, 98112 |
| Polyclinic First Hill | Seattle, Washington, United States, 98122 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington, United States, 98195 |
| Evergreen Hematology and Oncology, PS | Spokane, Washington, United States, 99218 |
| Cancer Care Northwest - Spokane South | Spokane, Washington, United States, 99202 |
| Wenatchee Valley Medical Center | Wenatchee, Washington, United States, 98801-2028 |
| Rocky Mountain Oncology | Casper, Wyoming, United States, 82609 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, United States, 82801 |