A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using PET Imaging

Trial Purpose and Description

Trial Purpose

This study is investigational and is being done to find out if it is possible to use early periodic PET scans to identify those patients who are not responding to a combination of standard chemotherapy called "ABVD" (the drugs doxorubicin, bleomycin, vinblastine and dacarbazine). This approach would allow an earlier switch to a more intensive combination chemotherapy called "BEACOPP" (the drugs bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone). We would like to find out if the experimental treatment of switching from ABVD to BEACOPP using periodic PET scanning will improve the chances that your Hodgkin lymphoma will be cured. We also want to compare what kind of side effects this experimental treatment can cause and how often they occur.

Participation Guidelines

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
  • Previously untreated stage III or IV disease
  • No nodular lymphocyte predominant disease
• Bidimensionally measurable disease
• Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
  • Tissue obtained from core biopsies allowed
  • No tissue obtained from needle aspirations or cytologies
• Must have known HIV status
  • No multi-drug resistant HIV infection, CD4 counts < 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients
  • HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count > 250/μL at any time within 8 months prior to HL diagnosis allowed
• Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
• Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days
  • Combined PET/CT scans required
  • No older "stand-alone" FDG-PET scans
  • No low-resolution "localization" CT scans as part of a combined PET/CT scans

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes measured within the past 28 days
• Serum estradiol (women only), testosterone (men only), FSH and LH (both men and women) levels must be drawn within 60 days prior to registration
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
• No significant cardiac abnormalities as assessed by MUGA scan or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms
• Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
  • Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
• Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
• No significant lung disease with abnormal lung function tests (i.e., DLCO > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
• No requirement for continuous supplemental oxygen therapy
• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
• No prior solid organ transplantation

Sponsor:

Southwest Oncology Group

Dates:

June 2012

Last Updated:

Study HIC#:

1101007919

Clinicaltrials.gov ID: Yale7881847