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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.
Verified by National Cancer Institute (NCI), February 2010
First Received: January 13, 2009   Last Updated: February 6, 2010   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00822120
  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.


Condition Intervention Phase
Lymphoma
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
Drug: vincristine sulfate
Radiation: fludeoxyglucose F 18
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 (OS) [ 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 ]

Estimated Enrollment: 230
Study Start Date: July 2009
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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 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 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 for 7 years.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed classical Hodgkin lymphoma (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 < 350/mcL, or other concurrent AIDS-defining conditions in HIV-positive patients
    • HIV-positive patients with CD4 counts ≥ 350/mcL allowed
  • Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes measured within the past 28 days
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822120

  Show 158 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000630501, SWOG-S0816
Study First Received: January 13, 2009
Last Updated: February 6, 2010
ClinicalTrials.gov Identifier: NCT00822120     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Alkylating Agents
Etoposide
Lymphoma
Hodgkin Disease
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Bleomycin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010