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Summary

for people ages 18–60 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Details

OBJECTIVES:

Primary

  • To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
  • To estimate the 2-year PFS of patients who are PET-positive after treatment with 2 courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride, and prednisone (BEACOPP).

Secondary

  • To estimate the 2-year overall survival (OS) of patients treated with these regimens.
  • To estimate the response rate (i.e., complete and partial responses) in patients treated with these regimens.
  • To evaluate the toxicity of these response-adapted regimens.
  • 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 HIV-positive patients treated with these response-adapted regimens.

OUTLINE: This is a multicenter study.

All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens:

  • Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan.

Some patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy.

After completion of study treatment, patients are followed up periodically for 7 years.

Keywords

Lymphoma Nonneoplastic Condition stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma HIV infection Hodgkin Disease Cyclophosphamide Liposomal doxorubicin Etoposide phosphate Doxorubicin Prednisone Etoposide Vincristine Bleomycin Vinblastine Procarbazine

Eligibility

For people ages 18–60

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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • Kaiser Permanente Medical Center - San Francisco Geary Campus
    San Francisco, California, 94115, United States
  • Kaiser Permanente Fresno Medical Center
    Fresno, California, 93720, United States
  • Kaiser Permanente Medical Center - South San Francisco
    South San Francisco, California, 94080, United States
  • Kaiser Permanente Medical Center - Richmond
    Richmond, California, 94801, United States
  • Kaiser Permanente Medical Center - Oakland
    Oakland, California, 94611, United States
  • Kaiser Foundation Hospital - San Rafael
    San Rafael, California, 94903, United States
  • Kaiser Permanente Medical Center - Hayward
    Hayward, California, 94545, United States
  • Kaiser Permanente Medical Center - Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente Medical Center - Walnut Creek
    Walnut Creek, California, 94596, United States
  • Stanford Cancer Center
    Stanford, California, 94305-5824, United States
  • Kaiser Permanente Medical Center - Vallejo
    Vallejo, California, 94589, United States
  • Kaiser Permanente - Fremont
    Fremont, California, 94538, United States
  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
    Santa Clara, California, 95051, United States
  • Kaiser Permanente - Deer Valley
    Antioch, California, 94531, United States
  • Kaiser Permanente Medical Center - Vacaville
    Vacaville, California, 95688, United States
  • Kaiser Permanente Medical Center - Santa Teresa
    San Jose, California, 95119, United States
  • Kaiser Permanente Medical Center - Santa Rosa
    Santa Rosa, California, 95403, United States
  • Kaiser Permanente Medical Facility - Stockton
    Stockton, California, 95210, United States
  • South Sacramento Kaiser-Permanente Medical Center
    Sacramento, California, 95823, United States
  • University of California Davis Cancer Center
    Sacramento, California, 95817, United States
  • Kaiser Permanente Medical Center - Sacramento
    Sacramento, California, 95825, United States
  • Kaiser Permanente Medical Center - Roseville
    Roseville, California, 95661, United States
  • Kaiser Permanente Medical Group
    Panorama City, California, 91402, United States
  • Kaiser Permanente Medical Cener - Woodland Hills
    Woodland Hills, California, 91367, United States
  • Kaiser Permanente Medical Center - Los Angeles
    Los Angeles, California, 90027, United States
  • Kaiser Foundation Hospital - West Los Angeles
    Los Angeles, California, 90034, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010-3000, United States
  • Kaiser Permanente Medical Center - Baldwin Park
    Baldwin Park, California, 91706, United States
  • Kaiser Permanente Medical Center - Bellflower
    Bellflower, California, 90706, United States
  • Kaiser Permanente Medical Center - Harbor City
    Harbor City, California, 90710, United States
  • Kaiser Permanente Medical Center - Fontana
    Fontana, California, 92335, United States
  • Kaiser Permanente Medical Center - Anaheim/Orange County
    Anaheim, California, 92807, United States
  • Kaiser Permanente Medical Center - Riverside
    Riverside, California, 92505, United States
  • Kaiser Permanente - Irvine
    Irvine, California, 92618, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, United States
  • Kaiser Permanente Health Care
    San Marcos, California, 92078, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Southwest Oncology Group
ID
NCT00822120
Phase
Phase 2
Study Type
Interventional
Last Updated
April 2016