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| 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 |
| Estimated Enrollment: | 230 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
Must have known HIV status
PATIENT CHARACTERISTICS:
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 158 Study Locations| Study Chair: | Oliver W. Press, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| 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 |
|
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 |
|
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 |