Non Hodgkin Lymphoma Clinical Trial
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin’s Lymphoma
Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
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.
Full Description
OBJECTIVES:
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.
Eligibility Criteria
Documentation of Disease:
1.1 Histologically documented Hodgkin lymphoma subclassified according to the WHO modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system. Patients must have clinical stage IA, IB, IIA or IIB. Patients with "E" extensions will be eligible if all other criteria have been met. Nodular lymphocyte predominant Hodgkin lymphoma is excluded.
Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Fine needle aspirate (FNA) cytologies and bone marrow biopsies as the sole means of diagnosis are not acceptable.
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.
No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.
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
Age ≥ 16 years
Performance status 0-2
LVEF by ECHO or MUGA within institutional normal limits
DLCO ≥ 60% with no symptomatic pulmonary disease
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.
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.
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
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There are 42 Locations for this study
San Francisco California, 94115, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Chicago Illinois, 60637, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Baltimore Maryland, 21201, United States
Elkton MD Maryland, 21921, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
St. Joseph Michigan, 49085, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65201, United States
St Louis Missouri, 63110, United States
Grand Island Nebraska, 68803, United States
North Platte Nebraska, 69101, United States
Omaha Nebraska, 68198, United States
Voorhees New Jersey, 08043, United States
Buffalo New York, 14263, United States
Glens Falls New York, 12801, United States
New York New York, 10021, United States
New York New York, 10021, United States
Syracuse New York, 13057, United States
Syracuse New York, 13210, United States
Syracuse New York, 13215, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28233, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Kinston North Carolina, 28501, United States
Wilson North Carolina, 27893, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29615, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
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