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Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: filgrastim (Biological); rituximab (Biological); carboplatin (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); ifosfamide (Drug); prednisone (Drug); vincristine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Lode J. Swinnen, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

Summary

RATIONALE: 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin's lymphoma.

Clinical Details

Official title: Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning

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

Primary outcome: 2-year Progression-Free Survival (PFS)

Secondary outcome: 5-year Overall Survival

Detailed description: 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 Combination Chemotherapy (R-CHOP: R= Rituximab, C= Cyclophosphamide, H=

Doxorubicin Hydrochloride (Hydroxydaunomycin), O= Vincristine Sulfate (Oncovin), P= Prednisone): 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 Rituximab 375 mg/m2 IV Day 1, Ifosfamide

5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery 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. ACCRUAL: A total of 100 patients were accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

INCLUSION CRITERIA:

- 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

- Eastern Cooperative Oncology Group (ECOG) performance status 0-3

- For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated

Acquisition Scan (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)

EXCLUSION CRITERIA:

- Prior chemotherapy or radiation therapy for lymphoma

- Prior anthracyclines or platinum compounds used as systemic chemotherapy

- Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow

- Concurrent pentostatin or trastuzumab (Herceptin®)

- Pregnant or nursing

- 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 positive

Locations and Contacts

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States

Front Range Cancer Specialists, Fort Collins, Colorado 80528, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States

St. Joseph Medical Center, Bloomington, Illinois 61701, United States

Graham Hospital, Canton, Illinois 61520, United States

Memorial Hospital, Carthage, Illinois 62321, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Eureka Community Hospital, Eureka, Illinois 61530, United States

Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States

Galesburg Clinic, PC, Galesburg, Illinois 61401, United States

Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States

Mason District Hospital, Havana, Illinois 62644, United States

Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States

Hopedale Medical Complex, Hopedale, Illinois 61747, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

McDonough District Hospital, Macomb, Illinois 61455, United States

Moline, Illinois 61265, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois 61265, United States

BroMenn Regional Medical Center, Normal, Illinois 61761, United States

Community Cancer Center, Normal, Illinois 61761, United States

Community Hospital of Ottawa, Ottawa, Illinois 61350, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois 61350, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois 61615, United States

OSF St. Francis Medical Center, Peoria, Illinois 61637, United States

Proctor Hospital, Peoria, Illinois 61614, United States

Illinois Valley Community Hospital, Peru, Illinois 61354, United States

Perry Memorial Hospital, Princeton, Illinois 61356, United States

St. Margaret's Hospital, Spring Valley, Illinois 61362, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

McFarland Clinic, PC, Ames, Iowa 50010, United States

Bettendorf, Iowa 52722, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States

Mercy Capitol Hospital, Des Moines, Iowa 50307, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland 21204, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Foote Memorial Hospital, Jackson, Michigan 49201, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48912-1811, United States

St. Mary Mercy Hospital, Livonia, Michigan 48154, United States

St. Joseph Mercy Oakland, Pontiac, Michigan 48341-2985, United States

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan 48060, United States

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan 48601, United States

St. John Macomb Hospital, Warren, Michigan 48093, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota 55805-1983, United States

Miller - Dwan Medical Center, Duluth, Minnesota 55805, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

NYU Cancer Institute at New York University Medical Center, New York, New York 10016, United States

Aultman Cancer Center at Aultman Hospital, Canton, Ohio 44710-1799, United States

Christ Hospital Cancer Center, Cincinnati, Ohio 45219, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Lewistown Hospital, Lewistown, Pennsylvania 17044, United States

Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

Geisinger Medical Group - Scenery Park, State College, Pennsylvania 16801, United States

Mount Nittany Medical Center, State College, Pennsylvania 16803, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

CCOP - Main Line Health, Wynnewood, Pennsylvania 19096, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States

Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin 54701, United States

Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States

Dean Medical Center - Madison, Madison, Wisconsin 53717, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Saint Joseph's Hospital, Marshfield, Wisconsin 54449, United States

Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin 53226, United States

Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin 54548, United States

Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin 54501, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin 54481, United States

Marshfield Clinic - Wausau Center, Wausau, Wisconsin 54401, United States

Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin 54494, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2006
Last updated: April 10, 2014

Page last updated: August 23, 2015

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