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Spots Global Cancer Trial Database for Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma

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Trial Identification

Brief Title: Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma

Official Title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL)

Study ID: NCT01118026

Conditions

Lymphoma

Study Description

Brief Summary: This research is being done in order to improve treatment outcomes in patients diagnosed with bulky, early stage Hodgkin lymphoma and to reduce the side effects that are associated with use of radiation used in current treatments. The chemotherapy treatment in this study consists of a combination of four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This regimen (called ABVD) has been found to be effective in treating patients with Hodgkin lymphoma and is considered the standard of treatment used with radiation therapy in patients with bulky early stage Hodgkin lymphoma. As part of the evaluation of the effectiveness of the chemotherapy treatment, PET scans will be obtained during the course of therapy. The usefulness of this PET scan will be evaluated to determine whether radiation may be left out in the treatment of disease if the PET scan shows that the patient has responded to chemotherapy alone. The plan is to identify a group of patients using early PET scans in order to change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone). It is one of the most highly effective chemotherapy regimens for Hodgkin lymphoma, but is associated with more side effects than ABVD. Although it has become standard of care in Europe, its use has been more limited in the U.S. because of concerns about toxicity.

Detailed Description: This is single-arm phase II clinical trial of response-adapted therapy based on PET for bulky stage I and stage II Hodgkin lymphoma. A maximum of 123 patients will be entered to the study. The primary outcome of this study is progression-free survival (PFS), defined as the time from study entry to disease progression or death. Primary Objective: To determine the progression-free survival (PFS) at 36 months from enrollment for patients with bulky stage I and II Hodgkin lymphoma. All patients will begin treatment with ABVD. Patients who are PET negative after 2 cycles of chemotherapy will receive 6 cycles of ABVD without radiotherapy. Patients who are PET positive after 2 cycles of ABVD will then receive 4 cycles of escalated BEACOPP followed by IFRT. A comparison will be made of the 36-month PFS between patients who are PET positive and those who are PET negative following 2 cycles of ABVD. Secondary Objectives: 1. To evaluate the complete response (CR) rate of patients diagnosed with bulky stage I and II Hodgkin lymphoma following PET response-adapted chemotherapy with or without radiation therapy. 2. To determine the predictive value of FDG uptake using various semiquantitative approaches, at baseline, after 2 cycles of ABVD and at completion of therapy. 3. To determine the predictive value of volumetric vs. 2 dimensional (2-D) measurement changes on CT between baseline and after 2 cycles, at the end of chemotherapy (PET negative patients only) and after RT (PET positive patients only) and compare with PET parameters. 4. To determine if changes in both qualitative and semiquantitative FDG-PET findings between baseline and after cycle 2, at end of chemotherapy (PET negative patients only) and after RT (PET positive patients only) with combination analyses with incorporating changes obtained from dedicated CT scans, correlate with response and PFS. 5. To compare the predictive value of both qualitative and semiquantitative FDG-PET changes, 2-D and volumetric CT changes, and combinatorial analyses (PET+dedicated CT data) with molecular parameters, and conventional parameters, including IPS. 6. To assess whether elevated baseline serum soluble CD30 (sCD30), IL10, CCL17, and CCL22 correlate with clinical response and PFS. 7. To assess whether persistent or recurrent elevation of serial serum sCD30, IL10, CCL17, or CCL22 correlate with relapse/progression or PET scan results. 8. To confirm independently useful tissue biomarkers (bcl-2, MAL, FOXP3, CD68, GzB) for risk stratification in patients with bulky stage I and II Hodgkin lymphoma treated with this regimen. 9. To compare mediastinal bulk on standing PA and lateral chest x-ray (\> 0.33 maximum chest diameter) with chest CT (mass \> 10 cm). After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2-3 years, and then once a year for a maximum of ten years from the time of entry on the study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Saint Helena Hospital, Saint Helena, California, United States

Naval Medical Center -San Diego, San Diego, California, United States

Beebe Medical Center, Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Weiss Memorial Hospital, Chicago, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States

Memorial Regional Cancer Center Day Road, Mishawaka, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Union Hospital of Cecil County, Elkton, Maryland, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

Norris Cotton Cancer Center-Nashua, Nashua, New Hampshire, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Weill Medical College of Cornell University, New York, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States

Carolinas HealthCare System NorthEast, Concord, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Wayne Memorial Hospital, Goldsboro, North Carolina, United States

Iredell Memorial Hospital, Statesville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States

Saint Charles Hospital, Oregon, Ohio, United States

Flower Hospital, Sylvania, Ohio, United States

Mercy Saint Anne Hospital, Toledo, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

Saint Francis Hospital, Greenville, South Carolina, United States

Saint Francis Cancer Center, Greenville, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States

University of Vermont College of Medicine, Burlington, Vermont, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

Contact Details

Name: Ann S. LaCasce, MD

Affiliation: Dana-Farber Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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