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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-50203 | |||
| CDR0000370870 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxorubicin + vinblastine + gemcitabine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin hydrochloride | Drug | given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response | 24 weeks |
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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.
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Straus, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States | ||
| Beebe Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| 21355087 | Derived | 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. |
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| gemcitabine hydrochloride |
| Drug |
given IV |
|
| vinblastine | Drug | given IV |
|
| fludeoxyglucose F 18 positron-emission tomography (PET) scan | Procedure |
|
| CT scan | Procedure |
|
| 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 D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | 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 | Saint 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 | 69101-6598 | United States |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | 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 | 27599-7295 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | 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 | 27893-3428 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210-1240 | 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 Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000093542 | Gemcitabine |
| D014747 | Vinblastine |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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