A Phase II Trial of Response Adapted Therapy of Stage III-lV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging.
Once patient is registered to the study, they will begin treatment with a combination of chemotherapy drugs called and amp;quot;ABVD. and amp;quot;
After completing two cycles of ABVD chemotherapy, the patients disease will be studied using a full body PET/CT scan. If the PET/CT scan shows that their disease is inactive, then you will receive an additional 4 cycles of ABVD. If the PET scan shows that their disease is still active, then they will receive 6 cycles of BEACOPP chemotherapy.
* Cyclophosphamide x given as an infusion in your veins on Day 1.
* Doxorubicin x given as an infusion in your veins on Day 1.
* Etoposide x given as an infusion in your veins on Days 1, 2 and 3.
* Procarbazine x given as pills to be taken by mouth on Days 1 through 7.
* Prednisone x given as pills to be taken by mouth on Days 1 through 14
* Bleomycin x given as a short intravenous injection on Day 8.
* Vincristine x given as a short intravenous infusion on Day 8.
The BEACOPP therapy will be given on a 21-day cycle. If patient is given BEACOPP
therapy they will receive 6 cycles of this treatment. (For HIV-positive patients: they will
receive the same amount of treatment cycles, but the BEACOPP dosage will be less
-All patients must have previously untreated Stage III or IV classical Hodgkin lymphoma
(nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte depleted).
-Patients must be age 18-60
-Patients must have bidimensionally measurable disease within 28 days prior to registration
-Patients must have a unilateral or bilateral bone marrow biopsy performed within 42 days
prior to registration
-Patients must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND
baseline FDG-PET scan performed within 28 days prior to registration.Combined PET/CT scans are required for this study, and older "stand-alone" FDG-PET scans are not adequate for entry to this study
-Patients must not have received prior chemotherapy, radiation, or antibody therapy for
-Patients must have a Zubrod performance status of 0 - 2 (see Section 10.4).
-Serum erythrocyte sedimentation rate (ESR), LDH, hemoglobin, albumin, WBC, and
lymphocytes must be measured within 28 days prior to registration
-Serum FSH, LH,estradiol (women only), and testosterone (men only) levels must be drawn within 60 days prior to registration, to obtain baseline values.
-Patients with a history of hypertension or cardiac symptoms must have a MUGA scan or
an echocardiogram (ECHO) with no significant abnormalities and a cardiac ejection
fraction >= 45% within 42 days prior to registration.
-Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or
anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C
antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B
surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).
-Patient HIV status must be known prior to registration. HIV-positive patients must not
have multi-drug resistant HIV infection, CD4 counts < 150/mcL or other concurrent AIDS-defining
conditions. HIV-positive patients are eligible if they have CD4 counts >= 150/mcL at the time of enrollment OR if they had a documented CD4 count > 250 at any time within 8 months prior to
HL diagnosis, but will be analyzed separately in an independent cohort.
-Patients must not have significant lung disease with abnormal lung function tests (DLCO
> 25% below predicted after correction for hemoglobin) unless it is attributable to
lymphoma. Patients must not be requiring continuous supplemental oxygen therapy.
-Patients must not have had prior solid organ transplantation.
- No other prior malignancy is allowed except for the following: 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.
-Patients must not be pregnant or nursing due to the potential for congenital abnormalities
and the potential of this regimen to harm nursing infants. Women/men of reproductive
potential must have agreed to use an effective contraceptive method. A
woman is considered to be of "reproductive potential" if she has had menses at any time
in the preceding 12 consecutive months. In addition to routine contraceptive methods,
"effective contraception" also includes heterosexual celibacy and surgery intended to
prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a
hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point
a previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is responsible
for beginning contraceptive measures.
- All patients must be informed of the investigational nature of this study and must sign and
give written informed consent in accordance with institutional and federal guidelines.
- At the time of patient registration, the treating institution's name and ID number must be
provided to the Data Operations Center in Seattle in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered into the data base.
-Patients must have completed 2 cycles of ABVD with no evidence of disease progression.
-Patients must be planning to begin either continued ABVD or BEACOPP (escalated dose
for HIV-negative patients, standard for HIV-positive patients) within 10 days after the
interim PET/CT is done.