Phase 2 N=371 Treatment

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

Lymphoma · Nonneoplastic Condition

Bottom Line

View on ClinicalTrials.gov: NCT00822120 ↗

Enrolled (actual)

371

Serious AEs

1.5%

Results posted

Apr 2018

Primary outcome: Primary: Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. — 79 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bleomycin sulfate (Biological); filgrastim (Biological); ABVD regimen (Drug); BEACOPP regimen (Drug); cyclophosphamide (Drug); dacarbazine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	79	—
PRIMARY Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS	64	—
SECONDARY Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging	98	—
SECONDARY Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	100; 93	—
SECONDARY Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	3; 0; 0; 1; 0; 0	—
SECONDARY Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.	83	—
SECONDARY Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.	89	—
SECONDARY Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD	9; 0; 1; 1	—
SECONDARY Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	0; 1; 0; 0; 1; 0	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00822120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.