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Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
This phase II trial studies how well chemotherapy based on positron emission tomography (PET) scan works in treating patients with stage I or stage II Hodgkin lymphoma. 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 combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) from enrollment for patients with non-bulky stage I and II Hodgkin lymphoma. II. To compare the PFS of patients who are PET positive versus PET negative following 2 cycles of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD). SECONDARY OBJECTIVES: I. To evaluate the complete response (CR) rate of patients diagnosed with non-bulky stage I and II Hodgkin lymphoma following PET response-adapted chemotherapy with or without radiation therapy. II. To determine the predictive value of fludeoxyglucose (FDG) uptake using various semi-quantitative approaches, at baseline, after 2 cycles of AVBD and at completion of therapy. III. To determine the predictive value of volumetric changes on computed tomography (CT) vs 2-dimensional (2-D) analyses after 2 cycles and 4 cycles and compare with PET parameters with and without combination analyses (PET + dedicated CT data). IV. To compare the predictive value of metabolic parameters/changes that are measured both visually and semi-quantitatively, International Harmonization Project (IHP) criteria, 2-D and volumetric CT changes, molecular parameters, and conventional parameters, including International Prognostic Score (IPS). V. To assess whether elevated baseline circulating markers of inflammation (including soluble cluster of differentiation CD30 \[sCD\]30, soluble CD 163 \[CD163\], interleukin-10 (IL10), chemokine (C-C motif) ligand 17 (CCL17), and chemokine (C-C motif) ligand 22 \[CCL22\]) correlate with clinical response and PFS and PET scan results. VI. To assess whether persistent or recurrent elevated serial circulating markers of inflammation (including soluble CD30 \[sCD30\], soluble CD163 \[sCD163\], IL10, CCL17, or CCL22) correlate with relapse/progression or PET scan results. VII. To confirm independently useful tissue biomarkers for risk stratification in patients with non-bulky stage I and II Hodgkin lymphoma treated with this regimen. VIII. To compare mediastinal bulk on standing posterior-anterior (PA) and lateral chest x-ray (\> 0.33 maximum chest diameter) with chest CT (mass \> 10 cm). OUTLINE: ABVD CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 3-5 minutes, bleomycin sulfate IV over 3-5 minutes, 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. Patients then undergo PET scan. Patients achieving complete response (CR), partial response (PR), or stable disease (SD) with a negative PET scan receive 2 additional courses of ABVD chemotherapy in the absence of disease progression or unacceptable toxicity. Patients achieving CR, PR, or SD with a positive PET scan proceed to escalated BEACOPP chemotherapy. ESCALATED BEACOPP\* CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 3-5 minutes and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 45-60 minutes on days 1-3, procarbazine orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine IV on day 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after completion of BEACOPP chemotherapy, patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3½ weeks. NOTE: \* HIV-positive patients receive standard BEACOPP instead of escalated BEACOPP. Patients undergo fludeoxyglucose F\^18 PET/CT scan at baseline, and within 8-10 days after completion of chemotherapy. Patients also undergo additional PET/CT scans within 3-4 weeks after completion of ABVD or within 12 weeks after completion of BEACOPP and IFRT. Patients with a negative PET scan proceed to follow up. Patients with a positive PET scan undergo 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 biopsy is neither clinically appropriate nor medically feasible proceed to follow-up. Patients for whom biopsy is neither clinically indicated nor medically appropriate undergo a repeat PET/CT scan after 3 months. If PET/CT scan remains positive, patients undergo biopsy as above. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2-3 years, and then annually for a maximum of 5 years.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
Start Date
May 1, 2010
Primary Completion Date
February 1, 2016
Completion Date
January 1, 2018
Last Updated
June 14, 2021
164
ACTUAL participants
Bleomycin Sulfate
BIOLOGICAL
Doxorubicin Hydrochloride
DRUG
Procarbazine Hydrochloride
DRUG
Vinblastine Sulfate
DRUG
Dacarbazine
DRUG
Cyclophosphamide
DRUG
Etoposide phosphate
DRUG
prednisone
DRUG
Radiation Therapy
DRUG
Fludeoxyglucose F-18
RADIATION
computed tomography
PROCEDURE
Positron Emission Tomography
PROCEDURE
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT07388563
NCT06263491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05529069