Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000331915 | Other Identifier | Clinical Trials.gov | |
| COG-AHOD0321 | Other Identifier | Children's Oncology Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use 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 giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate | Adequate tumor response is defined as achieving CR, VGPR or PR at any evaluation. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities | Toxic death, hepatic, cardiac or renal toxicity, hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities | Up to 4 weeks following the completion of therapy |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:
Not otherwise specified (NOS)
Mixed cellularity NOS
Lymphocytic depletion
Lymphocytic predominance
Paragranuloma
Granuloma
Sarcoma
Nodular sclerosis
Measurable disease by clinical or radiographic criteria
Relapsed or refractory to conventional therapy
No stage IA or IIA nodal disease previously treated with any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
Creatinine based on age as follows:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
See Disease Characteristics
More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week of each other)
No other concurrent chemotherapy
Endocrine therapy
No concurrent steroids, including corticosteroids as an antiemetic or for control of graft-versus-host disease
Concurrent corticosteroids allowed only for the following indications:
Radiotherapy
Surgery
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Cole, MD | Rutgers Cancer Institute of New Jersey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20863157 | Result | Cole PD, McCarten KM, Drachtman RA, Alarcon Pd, Chen L, Trippett TM, Schwartz CL. Early [(1)(8)F]fluorodeoxyglucose positron emission tomography-based response evaluation after treatment with gemcitabine and vinorelbine for refractory Hodgkin disease: a children's oncology group report. Pediatr Hematol Oncol. 2010 Nov;27(8):650-7. doi: 10.3109/08880018.2010.504250. | |
| 19224841 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| gemcitabine hydrochloride | Drug | Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8 |
|
|
| vinorelbine tartrate | Drug | Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8 |
|
|
| 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 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California | 92354 | 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 |
| 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 |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Stanford Comprehensive Cancer Center - Stanford | Stanford | California | 94305 | 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 |
| 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 |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | 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 |
| Nemours Children's Clinic - 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 |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | 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 |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | 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 |
| 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 |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0238 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Spectrum Health Hospital - 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 |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | United States |
| Children's Hospitals and Clinics of Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| St. Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | United States |
| Overlook Hospital | Morristown | New Jersey | 07962 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Albany Medical Center Hospital | Albany | New York | 12208-3419 | United States |
| Brooklyn Hospital Center | Brooklyn | New York | 11201-5493 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | 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 |
| 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 |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | 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 |
| Tod Children's Hospital | Youngstown | Ohio | 44501 | United States |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | 97227 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-0001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-9786 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | United States |
| Greenville Hospital System Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| T.C. Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6310 | United States |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | 79106 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78466 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | 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 | 78207 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | 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 |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99220-2555 | United States |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | 98405 | United States |
| Madigan Army Medical Center - Tacoma | Tacoma | Washington | 98431 | United States |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia | 25302 | 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 |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| University of Alberta Hospital | Edmonton | Alberta | T6G 1Z2 | Canada |
| CHUS-Hopital Fleurimont | Sherbrooke | Alberta | J1H5N4 | Canada |
| Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | 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 |
| Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1V 4G2 | Canada |
| San Jorge Children's Hospital | Santurce | 00912 | Puerto Rico |
| Swiss Pediatric Oncology Group Geneva | Geneva | 1205 | Switzerland |
| Cole PD, Schwartz CL, Drachtman RA, de Alarcon PA, Chen L, Trippett TM. Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's disease: a children's oncology group report. J Clin Oncol. 2009 Mar 20;27(9):1456-61. doi: 10.1200/JCO.2008.20.3778. Epub 2009 Feb 17. |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| 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 |
| 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 |
Not provided
Not provided