Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
RATIONALE: 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 more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving chemotherapy together with radiation therapy may kill more cancer cells. Diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors plan the best treatment.
PURPOSE: This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma.
Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: BEACOPP regimen
Drug: doxorubicin hydrochloride
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Other: laboratory biomarker analysis
Procedure: computed tomography
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Progression-free survival at 36 months from enrollment [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
- Complete response rate [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
- Standard uptake values (SUVs) for target sites measured at baseline, after course 2, and after completion of therapy [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Determination of the optimal cutoff for absolute decrease in maximum SUV body weight (SUVbw) and SUV lean body mass (SUVlbm), relative uptake in tumor vs various reference anatomic sites, IHP criteria as well as various cutoffs for post-therapy maxim ... [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Volumetric vs 2-dimensional (2-D) measurement changes for target lesions between baseline and after course 2, at the end of chemotherapy, and after IFRT [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Comparison of qualitative and semiquantitative fludeoxyglucose-PET findings/changes, 2-D and volumetric CT changes, and combinatorial analyses (PET + dedicated CT data) with molecular parameters and conventional parameters [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
- To determine the progression-free survival (PFS) at 36 months from enrollment of patients with bulky stage I or II Hodgkin lymphoma treated with ABVD alone or followed by escalated BEACOPP and involved-field radiation therapy.
- To evaluate the complete response rate in patients diagnosed with bulky stage I and II Hodgkin lymphoma following PET-response-adapted chemotherapy with or without radiotherapy.
- To determine the predictive value of semiquantitative evaluation of fludeoxyglucose (FDG) uptake using various semiquantitative approaches at baseline, after 2 courses of ABVD, and after completion of therapy.
- To determine the predictive value of volumetric vs 2-dimensional (2-D) measurement changes on CT scan between baseline and after 2 courses, at the end of chemotherapy (PET negative patients only), and after radiotherapy (PET positive patients only), and compare with PET parameters.
- To determine if changes in both qualitative and semiquantitative FDG-PET findings/changes between baseline and after course 2, at the end of chemotherapy (PET negative patients only), and after radiotherapy (PET positive patients only) with combination analyses incorporating changes obtained from dedicated CT scans, correlates with response and PFS.
- 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 International Prognostic Score.
- To assess whether elevated baseline serum soluble CD30 (sCD30), IL10, CCL17, and CCL22 correlate with clinical response and PFS.
- To assess whether persistent or recurrent elevation of serial serum sCD30, IL10, CCL17, or CCL22 correlate with relapse/progression or PET scan results.
- To confirm independently useful tissue biomarkers (bcl-2, MAL, FOXP3, GzB) for risk stratification in patients with bulky stage I or II Hodgkin lymphoma treated with this regimen.
OUTLINE: This is a multicenter study.
- ABVD chemotherapy: All patients receive doxorubicin hydrochloride IV over 3-5 minutes, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo a PET/CT scan and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients who are PET-positive proceed to escalated BEACOPP chemotherapy. Patients who are PET-negative receive 4 additional courses of ABVD chemotherapy in the absence of disease progression or unacceptable toxicity.
- Escalated BEACOPP chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5 minutes and cyclophosphamide IV over 60 minutes on day 1; etoposide IV over 60 minutes on days 1, 2, and 3; oral procarbazine hydrochloride once daily on days 1-7; oral prednisone on days 1-14; and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo another PET/CT scan and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients then undergo involved-field radiation therapy 5 days per week for 3½ weeks (for a total of 30.6 Gy).
Within 3-8 weeks after completion of chemotherapy, patients undergo an additional PET/CT scan (utilizing fludeoxyglucose F 18) and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients who are PET-negative proceed to follow up. Patients who are PET-positive undergo a biopsy*, patients with a negative biopsy proceed to follow up, and patients with a positive biopsy are treated at the discretion of the investigator.
NOTE: *Patients for whom a biopsy is neither clinically appropriate nor medically feasible proceed to follow up. Patients who defer the biopsy undergo scanning 3 months later and then undergo biopsy as above.
Blood and serum samples may be collected periodically for biomarker and IHC analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for 7 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118026
|United States, Delaware|
|CCOP - Christiana Care Health Services||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-623-4450|
|United States, District of Columbia|
|MedStar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Bruce Cheson 202-444-7932|
|United States, Illinois|
|University of Chicago Cancer Research Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424|
|Evanston, Illinois, United States, 60201-1781|
|Contact: Clinical Trials Office - Evanston Hospital 847-570-1381|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ann S. LaCasce, MD 617-632-5959|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Nancy L. Bartlett, MD 314-362-5654|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Nancy Bartlett 314-362-5654|
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-6805|
|Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756-0002|
|Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 firstname.lastname@example.org|
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University||Recruiting|
|New York, New York, United States, 10021|
|Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848|
|SUNY Upstate Medical University Hospital||Recruiting|
|Syracuse, New York, United States, 13210|
|Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|Contact: Mark Mogul 304-399-6503|
|Carolinas Medical Center/Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28206|
|Contact: David Miller 980-442-5221|
|Blumenthal Cancer Center at Carolinas Medical Center||Recruiting|
|Charlotte, North Carolina, United States, 28232-2861|
|Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884|
|Batte Cancer Center at Northeast Medical Center||Recruiting|
|Concord, North Carolina, United States, 28025|
|Contact: David W. Miller, MD 704-302-8300|
|Wayne Memorial Hospital, Incorporated||Recruiting|
|Goldsboro, North Carolina, United States, 27534|
|Contact: James N. Atkins, MD 919-580-0000|
|Iredell Memorial Hospital||Recruiting|
|Statesville, North Carolina, United States, 28677|
|Contact: Ruby Grimm 704-873-2219|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: David Hurd 336-716-2088|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210-1240|
|Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 Jamesline@osumc.edu|
|United States, Vermont|
|Central Vermont Medical Center/National Life Cancer Treatment||Recruiting|
|Berlin, Vermont, United States, 05602|
|Contact: Emiliano Mugnaini 802-656-5487|
|Fletcher Allen Health Care - University Health Center Campus||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298-0037|
|Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939|
|Principal Investigator:||Ann S. LaCasce, MD||Dana-Farber Cancer Institute|