Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II 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 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.
PURPOSE: This phase II trial is studying how well chemotherapy based on PET scan works in treating patients with stage I or 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:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma|
- Progression-free survival (PFS) at 36 months [ Designated as safety issue: No ]
- PFS after 2 courses of ABVD [ Designated as safety issue: No ]
- Complete response rate [ Designated as safety issue: No ]
- FDG/PET uptake [ Designated as safety issue: No ]
- Volumetric changes on CT scan after courses 2 and 4 of ABVD [ Designated as safety issue: No ]
- Changes in metabolic parameters [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
- To determine the progression-free survival (PFS) of patients with non-bulky stage I or II Hodgkin lymphoma treated with ABVD alone or followed by escalated BEACOPP and involved-field radiation therapy.
- To compare the PFS of patients who are PET positive versus PET negative after 2 courses of ABVD.
- To evaluate the complete response rate in patients treated with these regimens.
- To determine the predictive value of semiquantitative evaluation of FDG/PET uptake using various approaches at baseline, after 2 courses of AVBD, and at completion of therapy.
- To determine the predictive value of volumetric changes on CT scan after courses 2 and 4 of ABVD and compare with PET parameters with and without combination analyses (PET+dedicated CT data).
- To compare the predictive value of metabolic parameters/changes both visual and quantitative, IHP criteria, volumetric CT changes, molecular parameters, and conventional parameters, including initial 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 elevated serial serum sCD30, IL10, CCL17, or CCL22 correlate with relapse/progression or PET scan results.
- To confirm independently useful tissue biomarkers for risk stratification in patients with non-bulky stage I and II Hodgkin lymphoma treated with these regimens.
- To compare mediastinal bulk on standing PA and lateral chest x-ray (> 0.33 maximum chest diameter) with chest CT (mass > 10 cm).
OUTLINE: This is a multicenter study.
- ABVD chemotherapy: Patients receive doxorubicin hydrochloride 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, oral procarbazine on days 1-7, oral prednisone 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.
Patients may undergo blood sample collection for biomarker studies.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132807
Show 95 Study Locations
|Principal Investigator:||David J. Straus, MD||Memorial Sloan-Kettering Cancer Center|