Response-Based Therapy Assessed by PET Scan in Treating Patients with Stage IA-IIB Hodgkin Lymphoma
This phase II trial studies how well response-based therapy assessed by positron emission tomography (PET) scan works in treating patients with stage IA-IIB Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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.
Inclusion Criteria
- Histologically documented Hodgkin lymphoma subclassified according to the World Health Organization (WHO) modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system; patients must have clinical stage IA, IB, IIA or IIB; patients with “E” extensions will be eligible if all other criteria have been met; nodular lymphocyte predominant Hodgkin lymphoma is excluded * Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; fine needle aspirates are not acceptable; if multiple specimens are available, please submit the most recent; failure to submit pathology materials within 60 days of patient registration will be considered a major protocol violation
- Patients must have a mediastinal mass > 0.33 maximum intrathoracic diameter on standing posterior-anterior chest x-ray or mass measuring > 10 cm in its largest diameter
- No “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
- Patients may have had one cycle only of ABVD prior to enrolling on study; no other prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma is allowed; if patient has had one cycle of ABVD, in order to be eligible to enroll on Cancer and Leukemia Group B (CALGB) 50801, the patient must have had all of the following tests prior to starting the first cycle of ABVD: * Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multi gated acquisition (MUGA) * Pulmonary function tests (PFTs) (including diffusing capacity of the lung for carbon monoxide [DLCO]/forced vital capacity [FVC]) * CT scan (neck**, chest, abdomen, pelvis) * FDG-PET/CT scan * Chest X-ray, posterior-anterior (PA) & lateral * Complete blood count (CBC), differential, platelets * Erythrocyte sedimentation rate (ESR) * Serum creatinine * Glucose * Aspartate aminotransferase (AST) * Alkaline phosphatase * Bilirubin * Lactate dehydrogenase (LDH) ** Patients with a negative FDG-PET/CT scan do not need to have had a dedicated neck CT scan prior to starting the previous cycle of ABVD
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- LVEF by ECHO or MUGA within institutional normal limits unless thought to be disease related; DLCO >= 60% with no symptomatic pulmonary disease unless thought to be disease related
- Patients with known human immunodeficiency virus (HIV) must have a CD4 count > 350 and be on concurrent antiretrovirals; patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; an HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk
- Non-pregnant and non-nursing; due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
- Absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000/uL
- Serum creatinine =< 2 mg/dL
- Bilirubin* =< 2 x upper limit of normal * In the absence of Gilbert’s disease
- AST =< 2 x upper limit of normal
Additional locations may be listed on ClinicalTrials.gov for NCT01118026.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVE:
I. To determine the progression-free survival (PFS) at 36 months from enrollment for patients with bulky stage I and II Hodgkin lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate the complete response (CR) rate of patients diagnosed with bulky stage I and II Hodgkin lymphoma following positron emission tomography (PET)-response-adapted chemotherapy with or without radiation therapy.
II. To determine the predictive value of fludeoxyglucose (FDG) uptake using various semiquantitative approaches at baseline, after 2 cycles of doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine (ABVD), and at completion of therapy.
III. To determine the predictive value of volumetric versus (vs.) 2-dimensional (2-D) measurement changes on computed tomography (CT) between baseline and after 2 cycles, at the end of chemotherapy (PET negative patients only), and after radiotherapy (RT) (PET positive patients only) and compare with PET parameters.
IV. 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.
V. 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 (IPS).
VI. To assess whether elevated baseline serum soluble CD30 (sCD30), interleukin (IL)10, CCL17, and CCL22 correlate with clinical response and PFS.
VII. To assess whether persistent or recurrent elevation of serial serum sCD30, IL10, CCL17, or CCL22 correlate with relapse/progression or PET scan results.
VIII. To confirm independently useful tissue biomarkers (B-cell lymphoma 2 [bcl-2], MAL, FOXP3, CD68, granzyme B [GzB]) for risk stratification in patients with bulky stage I and II Hodgkin lymphoma treated with this regimen.
IX. 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: All patients receive doxorubicin hydrochloride intravenously (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 bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, procarbazine hydrochloride and prednisone (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; procarbazine hydrochloride orally (PO) once daily (QD) on days 1-7; prednisone PO 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 3.5 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.
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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorAnn Steward LaCasce
- Primary IDCALGB-50801
- Secondary IDsNCI-2011-02034, CDR0000669076
- ClinicalTrials.gov IDNCT01118026