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

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Health Professionals

Diseases and Conditions Researched

Hodgkin Lymphoma

What is the purpose of this trial?

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

Age: 18 Years and older
Gender: Both

Click here for detailed participation information for this trial.

Sponsor:	Southwest Oncology Group
Study HIC#:	1101007919

Official title

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

Condition

Hodgkin Lymphoma

Trial Purpose

The co-primary objectives are:

To estimate the 2-year progression-free survival (PFS) in HIV-negative patients with advanced stage Hodgkin Lymphoma (HL) treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of adriamycin, bleomycin,vinblastine, and dacarbazine (ABVD).
To estimate the 2-year PFS in the subset of HIV-negative patients with advanced stage HL who are PET-positive after 2 cycles of ABVD and are subsequently treated with escalated dose BEACOPP.

Secondary objectives include:

To estimate the 2-year overall survival (OS) for HIV-negative patients treated with response- adapted therapy.
To estimate the response rate (complete and partial) for HIV-negative patients treated with response- adapted therapy.
To evaluate the toxicity of this response-adapted regimen.
To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies.
To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of a cohort of HIV-positive patients with HL treated with response-adapted therapy.The use of cycle-2 PET scanning in HIV infection will be done to provide preliminary data for this strategy in HIV-infected patients.
To prospectively identify serum and tissue biomarkers associated with progression-free and overall survival of patients with HL treated with response-adapted therapy. Biologic features meriting specific investigation include the degree of tumor cell infiltration with Tregulatory cells, the FOXP3/Granzyme B ratio, and the expression of MAL or Bcl-2 in biopsy samples, and TARC levels in serum specimens.
To prospectively evaluate HIV viral load and CD4 cells in the cohort of HIV-positive patients with HL treated with response-adapted therapy.

Participation Guidelines

Age: 18 Years and older
Gender: Both

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