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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT00086801

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 42 Locations for this study

See Locations Near You

UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital at Howard Regional Health System
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
Iowa Blood and Cancer Care
Cedar Rapids Iowa, 52402, United States
St. Luke's Hospital
Cedar Rapids Iowa, 52402, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph Michigan, 49085, United States
University of Minnesota Medical Center - Fairview
Minneapolis Minnesota, 55455, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis Missouri, 63110, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island Nebraska, 68803, United States
Great Plains Regional Medical Center
North Platte Nebraska, 69101, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse New York, 13057, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Community General Hospital
Syracuse New York, 13215, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Lenoir Memorial Cancer Center
Kinston North Carolina, 28501, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Bon Secours St. Francis Health System
Greenville South Carolina, 29601, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
Mountainview Medical
Berlin Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT00086801

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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