S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

Not Recruiting

Trial ID: NCT00822120

Purpose

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. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.

Official Title

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

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Eligibility


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, lactate dehydrogenase (LDH), hemoglobin,
   albumin, white blood cell count (WBC), and lymphocytes measured within the past 28
   days

   - Serum estradiol (women only), testosterone (men only), follicle stimulating hormone
   (FSH) and luteinizing hormone (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 multiple gated acquisition scan
   (MUGA) 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., diffusing
   capacity of lung for carbon monoxide (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

Intervention(s):

biological: bleomycin sulfate

biological: filgrastim

drug: vinblastine sulfate

drug: ABVD regimen

drug: BEACOPP regimen

drug: cyclophosphamide

drug: dacarbazine

drug: doxorubicin hydrochloride

drug: etoposide

drug: prednisone

drug: procarbazine hydrochloride

drug: vincristine sulfate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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