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| ID | Type | Description | Link |
|---|---|---|---|
| CCG-A5981 | Other Identifier | Children's Cancer Group | |
| CDR0000068325 | Other Identifier | Clinical Trials.gov | |
| NCI-2012-02366 | Other Identifier | NCI | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, 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: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified by prior therapy (minimally pretreated, low-risk vs heavily pretreated, high-risk).
Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator.
Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.
Patients are followed at 1, 6, and 12 months and then periodically thereafter.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 1.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ifosfamide, vinorelbine, filgrastim) | Experimental | Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response includes complete response (CR) or partial response (PR). | After 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg | Will be calculated. | After 2 cycles |
| Biologic markers | At enrollment and during/after therapy |
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DISEASE CHARACTERISTICS:
Histologically confirmed refractory or relapsed Hodgkin's lymphoma
In first relapse
Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed
Not enrolled on POG-9426 unless there is an extranodal site of recurrence
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Trippett, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Pedro A. de Alarcon, MD | St. Jude Children's Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
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| ifosfamide | Drug | V over 24 hours on days 1-4 |
|
| vinorelbine tartrate | Drug | IV over 6-10 minutes on days 1 and 5. |
|
| Cardiac, hepatic, renal, hematologic toxicity | Within 1 month of completion of therapy |
| Toxic death | Within 1 month of Completion of therapy |
| Phoenix Children's Hospital |
| Phoenix |
| Arizona |
| 85016-7710 |
| United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Southern California Permanente Medical Group | Downey | California | 90242-2814 | United States |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California | 90801 | United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Children's Hospital Central California | Madera | California | 93638-8762 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Kaiser Permanente Medical Center - Oakland | Sacramento | California | 95825 | United States |
| Children's Hospital and Health Center - San Diego | San Diego | California | 92123-4282 | United States |
| Stanford Cancer Center at Stanford University Medical Center | Stanford | California | 94305 | United States |
| Children's Hospital Cancer Center | Denver | Colorado | 80218-1088 | United States |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | 06360-2875 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19899 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | United States |
| M.D. Anderson Cancer Center - Orlando | Orlando | Florida | 32806 | United States |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 95813 | United States |
| St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | 83712-6297 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794-9620 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| St. Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0293 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| Children's Hospital of New Orleans | New Orleans | Louisiana | 70118 | United States |
| CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Scarborough | Maine | 04074-9308 | United States |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | 21215 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids | Michigan | 49503-2560 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-5341 | United States |
| Children's Hospital of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Keesler Medical Center - Keesler Air Force Base | Keesler Air Force Base | Mississippi | 39534-2511 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Brooklyn Hospital Center | Brooklyn | New York | 11201-5493 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York | 11794-8174 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195-5217 | United States |
| Children's Medical Center - Dayton | Dayton | Ohio | 45404-1815 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Institute of Oncology at Vilnius University | Portland | Oregon | 97227 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Hospital System Cancer Center | Greenville | South Carolina | 29605 | United States |
| T.C. Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas | 79106 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104-9958 | United States |
| Baylor University Medical Center - Houston | Houston | Texas | 77030-2399 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| INOVA Fairfax Hospital | Fairfax | Virginia | 22031 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
| Carilion Cancer Center of Western Virginia | Roanoke | Virginia | 24029 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| Madigan Army Medical Center - Tacoma | Tacoma | Washington | 98431 | United States |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia | 25701 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Prince of Wales Private Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T2T 5C7 | Canada |
| Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | H3H 1P3 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec | Ste-Foy | Quebec | G1V 4G2 | Canada |
| Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D007069 | Ifosfamide |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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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