| Conditions: |
|
Lymphoma |
| 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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT00822120 |
| Primary Contact: |
|
Study Chair
Oliver W. Press, MD, PhD
Fred Hutchinson Cancer Research Center
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Charleston, South Carolina 29425
United States
Clinical Trials Office - Hollings Cancer Center at Medical Uni
Phone: 843-792-9321
Site Status: Recruiting |