Trial record 1 of 1 for:    NCT00822120
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00822120
First received: January 13, 2009
Last updated: February 21, 2014
Last verified: February 2014

January 13, 2009
February 21, 2014
July 2009
December 2014   (final data collection date for primary outcome measure)
  • 2-year progression-free survival (PFS) of HIV-negative patients after treatment with 2 courses of ABVD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
  • 2-year PFS of patients who are PET-positive after treatment with ABVD and escalated-dose BEACOPP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
  • 2-year progression-free survival (PFS) of HIV-negative patients after treatment with 2 courses of ABVD [ Designated as safety issue: No ]
  • 2-year PFS of patients who are PET-positive after treatment with ABVD and escalated-dose BEACOPP [ Designated as safety issue: No ]
  • 2-year overall survival [ Designated as safety issue: No ]
  • Complete and partial response rates [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Feasibility of centralized, real-time review of FDG-PET imaging [ Designated as safety issue: No ]
  • Overall response rate, complete response rate, PFS, and OS of HIV-positive patients treated with response-adapted regimens [ Designated as safety issue: No ]
  • Serum and tissue biomarkers associated with PFS and OS [ Designated as safety issue: No ]
  • HIV viral load and CD4 cells in HIV-positive patients treated with response-adapted regimens [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00822120 on ClinicalTrials.gov Archive Site
  • 2-year overall survival (OS) for HIV-negative patients treated with response- adapted therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
  • Complete and partial response rates for HIV-negative patients treated with response- adapted therapy [ Time Frame: 7 months after registration ] [ Designated as safety issue: No ]
    Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal
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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
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Nonneoplastic Condition
  • Biological: bleomycin sulfate
  • Biological: filgrastim
  • Drug: 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
  • Experimental: HIV Positive, PET Negative: BEACOPP standard
    Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: BEACOPP regimen
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisone
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
  • Experimental: HIV Negative, PET Positive: BEACOPP escalated
    Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles
    Interventions:
    • Biological: bleomycin sulfate
    • Biological: filgrastim
    • Drug: BEACOPP regimen
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisone
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
  • Active Comparator: HIV Positive, PET Negative: ABVD
    Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: ABVD regimen
    • Drug: dacarbazine
    • Drug: doxorubicin hydrochloride
    • Drug: vinblastine sulfate
  • Active Comparator: HIV Negative, PET Negative: ABVD
    Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: ABVD regimen
    • Drug: dacarbazine
    • Drug: doxorubicin hydrochloride
    • Drug: vinblastine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
April 2020
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Megan Hardin 2106148808 ext 1014 mhardin@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org
United States
 
NCT00822120
CDR0000630501, S0816, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
Southwest Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP