Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Nonneoplastic Condition

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief 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 c...

Detailed Description

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 fludeoxyglucos...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2022

    Estimated Enrollment :

    371 Patients enrolled

    Trial Details

    Trial ID

    NCT00822120

    Start Date

    July 1 2009

    End Date

    June 30 2022

    Last Update

    August 18 2022

    Active Locations (423)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 106 (423 locations)

    1

    Arizona Cancer Center at University Medical Center North

    Tucson, Arizona, United States, 85719

    2

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024

    3

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    Highlands Oncology Group - Springdale

    Rogers, Arkansas, United States, 72758