Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma
NCT ID: NCT00086801
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2004-05-31
2011-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.
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Detailed Description
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Primary
* Determine the complete response rate in patients with newly diagnosed stage IA, IB, IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and gemcitabine.
Secondary
* Determine the event-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful in predicting clinical relapse and determining the presence of residual disease in these patients after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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doxorubicin + vinblastine + gemcitabine
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
doxorubicin hydrochloride
given IV
gemcitabine hydrochloride
given IV
vinblastine
given IV
fludeoxyglucose F 18 positron-emission tomography (PET) scan
CT scan
Interventions
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doxorubicin hydrochloride
given IV
gemcitabine hydrochloride
given IV
vinblastine
given IV
fludeoxyglucose F 18 positron-emission tomography (PET) scan
CT scan
Eligibility Criteria
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Inclusion Criteria
* Note: Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible.
1.2 Patients may not have a mediastinal mass \> 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy \> 10 cm in its largest diameter.
1.3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies are preferred but not required.
2. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.
3. Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and \> 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans). Lesions that are considered intrinsically non-measurable include the following:
* bone lesions
* leptomeningeal disease
* ascites
* pleural/pericardial effusion
* inflammatory breast disease
* lymphangitis cutis/pulmonis
* abdominal masses that are not confirmed and followed by imaging techniques
* cystic lesions
* lesions that are situated in a previously irradiated area
4. Age ≥ 16 years
5. Performance status 0-2
6. LVEF by ECHO or MUGA within institutional normal limits
7. DLCO ≥ 60% with no symptomatic pulmonary disease
8. No known HIV infection. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this chemotherapy regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.
9. Non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.
10. Initial Required Laboratory Data:
* ANC ≥ 1000/μL
* Platelet count ≥ 100,000/μL
* Serum Creatinine ≤ 2 mg/dL
* Bilirubin ≤ 2 mg/dL
* AST ≤ 2 x upper limit of normal
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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David Straus, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States
Great Plains Regional Medical Center
North Platte, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Community General Hospital
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Countries
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References
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Kostakoglu L, Straus DJ, Schöder H, et al.: Validation of the International Harmonization Project (IHP) Guidelines in early stage Hodgkin lymphoma (HL) treated with adriamycin, vinblastine and gemcitabine (AVG) (CALGB 50203): early results. [Abstract] Blood 112 (11): A-1460, 2008.
Straus D, LaCase A, Juweid M, et al.: Doxorubicin, vinblastine and gemcitabine (AVG), a novel regimen excluding bleomycin for the treatment of early stage Hodgkin lymphoma (HL): results of CALGB 50203. [Abstract] Blood 110 (11): A-214, 2007.
Straus DJ, Johnson JL, LaCasce AS, Bartlett NL, Kostakoglu L, Hsi ED, Schoder H, Hall NC, Jung SH, Canellos GP, Schwartz LH, Takvorian RW, Juweid ME, Cheson BD; Cancer and Leukemia Group B. Doxorubicin, vinblastine, and gemcitabine (CALGB 50203) for stage I/II nonbulky Hodgkin lymphoma: pretreatment prognostic factors and interim PET. Blood. 2011 May 19;117(20):5314-20. doi: 10.1182/blood-2010-10-314260. Epub 2011 Feb 25.
Other Identifiers
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CALGB-50203
Identifier Type: -
Identifier Source: secondary_id
CDR0000370870
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-50203
Identifier Type: -
Identifier Source: org_study_id
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