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| ID | Type | Description | Link |
|---|---|---|---|
| COG-9917 | Other Identifier | Children's Oncology Group | |
| CDR0000067965 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy 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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS involvement vs B-ALL with CNS involvement).
Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day 40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of: A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24 hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B).
Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1 hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until blood counts recover. Patients with CNS involvement receive a total of 7 courses of treatment (A-B-C-A-B-A-B).
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAGE III NHL (Trt 1) | Experimental | A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABA |
|
| STAGE IV NHL, -CNS (Trt 2) | Experimental | A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABAB |
|
| STAGE IV, +CNS (Trt 3) | Experimental | A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy. Treatment ABCABAB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Assess the effect of high dose methotrexate in combination with standard treatment per the POG 9317 protocol on 1-year event-free survival (EFS), monitor and assess toxicity, and estimate the hospitalization costs for the treatment of toxicity related side effects. | 1 year |
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DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma
Histologically confirmed B-cell acute lymphocytic leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Hazem H. Mahmoud, MD | Carol G. Simon Cancer Center at Morristown Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
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| B-ALL, -CNS (Trt 2) |
| Experimental |
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. Treatment ABABAB |
|
| B-ALL, +CNS (Trt 3) | Experimental | A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy. Treatment ABCABAB |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| cytarabine | Drug | Given IV |
|
|
| dexamethasone | Drug | Given IV |
|
|
| doxorubicin hydrochloride | Drug | Given IV |
|
|
| etoposide | Drug | Given IV |
|
|
| ifosfamide | Drug | Given IV |
|
|
| leucovorin calcium | Drug | Given IV |
|
|
| methotrexate | Drug | Given IV |
|
|
| vincristine sulfate | Drug | Given IV |
|
|
| University of South Alabama Medical Center |
| Mobile |
| Alabama |
| 36617-2293 |
| United States |
| MBCCOP - Gulf Coast | Mobile | Alabama | 36688 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| University of California San Diego Cancer Center | La Jolla | California | 92093-0658 | United States |
| Lucile Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente-Southern California Permanente Medical Group | San Diego | California | 92120 | United States |
| Children's Hospital and Health Center | San Diego | California | 92123-4282 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051-5386 | United States |
| Yale Comprehensive Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Shands Hospital and Clinics, University of Florida | Gainesville | Florida | 32610-100277 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| University of Miami-Jackson Memorial Hospital Medical Center | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176-2197 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32803 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| CCOP - Florida Pediatric | Tampa | Florida | 33682-7757 | United States |
| St. Mary's Hospital | West Palm Beach | Florida | 33407 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859-5000 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Children's Memorial Hospital, Chicago | Chicago | Illinois | 60614 | United States |
| Hope Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Portland | Maine | 04101 | United States |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Boston Floating Hospital Infants and Children | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri | 65212 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico School of Medicine | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Schneider Children's Hospital | New Hyde Park | New York | 11042 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-7775 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Mission Saint Joseph's Health System | Asheville | North Carolina | 28801 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Presbyterian Healthcare | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| East Carolina University School of Medicine | Greenville | North Carolina | 27858-4354 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Oklahoma Memorial Hospital | Oklahoma City | Oklahoma | 73126-0307 | United States |
| Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Children's Hospital of Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| James H. Quillen College of Medicine | Johnson City | Tennessee | 37614-0622 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105-2794 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78466 | United States |
| Texas Oncology P.A. | Dallas | Texas | 75230-2503 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0209 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas | 78236-5300 | United States |
| MBCCOP - South Texas Pediatric | San Antonio | Texas | 78229-3900 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7811 | United States |
| Scott and White Clinic | Temple | Texas | 76508 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042-3300 | United States |
| Naval Medical Center, Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Carilion Roanoke Community Hospital | Roanoke | Virginia | 24019 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-5000 | United States |
| West Virginia University Medical School-Charleston | Charleston | West Virginia | 25304 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506-9300 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54307-3508 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T2T 5C7 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Children's Hospital | 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 |
| McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Laval University Medical Center | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Centre Hospitalier de L'Universite Laval | Sainte-Foy | Quebec | GIV 4G2 | Canada |
| Academisch Ziekenhuis Groningen | Groningen | 9713 EZ | Netherlands |
| San Jorge Childrens Hospital | Santurce | 00912 | Puerto Rico |
| Swiss Pediatric Oncology Group Bern | Bern | CH 3010 | Switzerland |
| Clinique de Pediatrie | Geneva | 1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D014750 | Vincristine |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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