Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Biomarker/Laboratory analysis, Treatment | Active | Under 22 at diagnosis | NCI, Other | CDR0000467191 COG-ARAR0332, ARAR0332, NCT00304070 |
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer.
Further Study Information
OBJECTIVES:
Primary
- Describe the outcome of patients with stage I adrenocortical tumor (ACT) treated with surgery alone.
- Describe the outcome of patients with stage II ACT treated with radical adrenalectomy plus regional retroperitoneal lymph node dissection.
- Describe the outcome of patients with unresectable or metastatic ACT treated with mitotane and a cisplatin-based chemotherapy regimen.
Secondary
- Determine the feasibility and complications associated with the use of radical adrenalectomy and regional node dissection in these patients.
- Determine the toxicity of mitotane when administered with cisplatin, etoposide, and doxorubicin hydrochloride in patients with residual disease after surgery, inoperable tumors, or metastatic disease at diagnosis.
- Determine, prospectively, the frequency of tumor spillage during surgery in these patients.
- Determine the frequency of lymph node involvement in these patients.
- Compare the incidence and type of germline p53 mutation in non-Brazilian children and children from Southern Brazil.
- Characterize the cooperating molecular alterations associated with ACT.
- Determine the presence of embryonal markers in children with ACT.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage ( I vs II vs III or IV).
- Stratum I (stage I disease): Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.
- Stratum II (stage II disease): Patients undergo primary tumor resection and extended regional lymph node dissection followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.
- Stratum III (stage III or IV disease):
- Induction chemotherapy: Patients receive cisplatin-based chemotherapy comprising oral mitotane four times daily on days 1-21; cisplatin IV over 6 hours on days 1-2; etoposide IV over 1 hour on days 1-3; and doxorubicin hydrochloride IV over 1 hour on days 4-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6. Treatment repeats every 21 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or partial response proceed to surgery. Patients with a complete response proceed directly to continuation chemotherapy.
- Surgery: Patients with stage III disease undergo extended surgery and regional lymph node dissection. Patients with stage IV disease undergo primary tumor resection (if feasible) with regional lymph node dissection and resection of the metastases. Patients then proceed to continuation chemotherapy.
- Continuation chemotherapy: Patients receive additional cisplatin-based chemotherapy (as in induction chemotherapy) for 4-6 courses followed by mitotane alone for an additional 2 months. Patients with stage IV disease then proceed to additional surgery when feasible.
- Additional Surgery: Patients with stage IV disease may undergo additional primary tumor resection with regional lymph node dissection and resection (or re-resection) of the metastases.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adrenocortical carcinoma
- Newly diagnosed disease within the past 3 weeks
- Any disease stage allowed
PATIENT CHARACTERISTICS:
- Lansky performance status 60-100% (for patients ≤ 16 years old)
- Karnofsky performance status 60-100% (for patients > 16 years old)
- Absolute neutrophil count ≥ 750/mm^3
- Platelet count ≥ 75,000/mm^3
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
- 0.4 mg/dL (1 month to < 6 months)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to < 2 years of age
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT < 2.5 times ULN
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No previous chemotherapy for adrenocortical carcinoma
Trial Lead Organizations/Sponsors
Children's Oncology Group
National Cancer Institute| Carlos Rodriguez-Galindo |  | Study Chair |
| Raul Correa Ribeiro | |
Trial Sites
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| U.S.A. | |||
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| Alabama | |||
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| Birmingham | |||
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| Children's Hospital of Alabama at University of Alabama at Birmingham | |||
| Alyssa T Reddy | Ph: 205-934-0309 | ||
| UAB Comprehensive Cancer Center | |||
| Alyssa T Reddy | Ph: 205-934-0309 | ||
| Arizona | |||
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| Tucson | |||
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| Arizona Cancer Center at University of Arizona Health Sciences Center | |||
| Brenda J Wittman | Ph: 520-626-9008 | ||
| Arkansas | |||
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| Little Rock | |||
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| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |||
| David L Becton | Ph: 501-364-7373 | ||
| California | |||
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| Downey | |||
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| Southern California Permanente Medical Group | |||
| Robert M Cooper | Ph: 626-564-3455 | ||
| Long Beach | |||
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| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |||
| Jerry Z Finklestein | Ph: 562-933-5437 | ||
| Los Angeles | |||
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| Childrens Hospital Los Angeles | |||
| Leo Mascarenhas | Ph: 323-361-4110 | ||
| Madera | |||
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| Children's Hospital Central California | |||
| Vonda L Crouse | Ph: 866-353-5437 | ||
| Orange | |||
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| Children's Hospital of Orange County | |||
| Violet Shen | Ph: 714-997-3000 | ||
| Palo Alto | |||
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| Lucile Packard Children's Hospital at Stanford University Medical Center | |||
| Neyssa M Marina | Ph: 650-498-7061 | ||
| Email: clinicaltrials@med.stanford.edu | |||
| Colorado | |||
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| Aurora | |||
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| Children's Hospital Colorado Center for Cancer and Blood Disorders | |||
| Kelly W Maloney | Ph: 720-777-6672 | ||
| Denver | |||
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| Presbyterian - St. Luke's Medical Center | |||
| Jennifer J Clark | Ph: 866-775-6246 | ||
| Connecticut | |||
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| Hartford | |||
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| Connecticut Children's Medical Center | |||
| Michael S Isakoff | Ph: 860-545-9981 | ||
| Delaware | |||
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| Wilmington | |||
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| Alfred I. duPont Hospital for Children | |||
| Christopher N Frantz | Ph: 302-651-5755 | ||
| District of Columbia | |||
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| Washington | |||
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| Children's National Medical Center | |||
| Jeffrey S Dome | Ph: 202-884-2549 | ||
| Florida | |||
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| Fort Myers | |||
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| Lee Cancer Care of Lee Memorial Health System | |||
| Emad K Salman | Ph: 239-343-5333 | ||
| Jacksonville | |||
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| Nemours Children's Clinic | |||
| Eric S Sandler | Ph: 904-697-3529 | ||
| Miami | |||
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| University of Miami Sylvester Comprehensive Cancer Center - Miami | |||
| Julio C Barredo | Ph: 866-574-5124 | ||
| Email: Sylvester@emergingmed.com | |||
| Orlando | |||
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| Nemours Children's Clinic - Orlando | |||
| Ramamoorthy Nagasubramanian | Ph: 407-650-7150 | ||
| Pensacola | |||
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| Nemours Children's Clinic - Pensacola | |||
| Jeffrey H Schwartz | Ph: 904-697-3529 | ||
| Saint Petersburg | |||
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| All Children's Hospital | |||
| Gregory A Hale | Ph: 727-767-2423 | ||
| Email: HamblinF@allkids.org | |||
| Tampa | |||
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| St. Joseph's Children's Hospital of Tampa | |||
| Hardeo K Panchoosingh | Ph: 800-882-4123 | ||
| Hawaii | |||
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| Honolulu | |||
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| Tripler Army Medical Center | |||
| Tonya M Kratovil | Ph: 808-433-6336 | ||
| Illinois | |||
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| Chicago | |||
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| Ann and Robert H. Lurie Children's Hospital of Chicago | |||
| David O Walterhouse | Ph: 773-880-4562 | ||
| University of Chicago Cancer Research Center | |||
| Susan L Cohn | Ph: 773-834-7424 | ||
| Peoria | |||
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| Saint Jude Midwest Affiliate | |||
| Pedro A De Alarcon | Ph: 309-655-3258 | ||
| Springfield | |||
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| Simmons Cooper Cancer Institute | |||
| Gregory P Brandt | Ph: 217-545-7929 | ||
| Indiana | |||
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| Indianapolis | |||
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| Riley's Children Cancer Center at Riley Hospital for Children | |||
| Robert J Fallon | Ph: 317-274-2552 | ||
| Kentucky | |||
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| Lexington | |||
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| University of Kentucky Chandler Medical Center | |||
| Martha F Greenwood | Ph: 859-257-3379 | ||
| Louisville | |||
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| Kosair Children's Hospital | |||
| Salvatore J Bertolone | Ph: 866-530-5516 | ||
| Louisiana | |||
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| New Orleans | |||
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| Tulane Cancer Center at Tulane University Hospital and Clinic | |||
| Tammuella C Singleton | Ph: 504-988-6121 | ||
| Maryland | |||
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| Baltimore | |||
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| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |||
| Joseph M Wiley | Ph: 410-601-6120 | ||
| Email: pridgely@lifebridgehealth.org | |||
| Bethesda | |||
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| National Naval Medical Center | |||
| Anne B Warwick | Ph: 301-319-2100 | ||
| Massachusetts | |||
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| Boston | |||
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| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |||
| Carlos Rodriguez-Galindo | Ph: 866-790-4500 | ||
| Michigan | |||
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| Detroit | |||
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| Wayne State University | |||
| Yaddanapudi Ravindranath | Ph: 313-576-9363 | ||
| Lansing | |||
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| Breslin Cancer Center at Ingham Regional Medical Center | |||
| Renuka Gera | Ph: 517-334-2765 | ||
| Minnesota | |||
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| Minneapolis | |||
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| Masonic Cancer Center at University of Minnesota | |||
| Joseph P Neglia | Ph: 612-624-2620 | ||
| Missouri | |||
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| Kansas City | |||
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| Children's Mercy Hospital | |||
| Maxine L Hetherington | Ph: 816-234-3265 | ||
| Saint Louis | |||
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| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |||
| Frederick S Huang | Ph: 409-772-1950 | ||
| Nevada | |||
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| Las Vegas | |||
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| CCOP - Nevada Cancer Research Foundation | |||
| Jonathan Bernstein | Ph: 702-384-0013 | ||
| New Jersey | |||
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| Hackensack | |||
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| Hackensack University Medical Center Cancer Center | |||
| Burton E Appel | Ph: 201-996-2879 | ||
| Morristown | |||
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| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |||
| Steven L Halpern | Ph: 973-971-5900 | ||
| Newark | |||
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| Newark Beth Israel Medical Center | |||
| Peri Kamalakar | Ph: 973-926-7230 | ||
| Summit | |||
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| Overlook Hospital | |||
| Steven L Halpern | Ph: 973-971-5900 | ||
| New York | |||
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| Albany | |||
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| Albany Medical Center Hospital | |||
| Vikramjit S Kanwar | Ph: 518-262-3368 | ||
| Rochester | |||
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| James P. Wilmot Cancer Center at University of Rochester Medical Center | |||
| Jeffrey R Andolina | Ph: 585-275-5830 | ||
| North Carolina | |||
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| Chapel Hill | |||
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| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |||
| Stuart H Gold | Ph: 877-668-0683 | ||
| Durham | |||
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| Duke Cancer Institute | |||
| Susan G Kreissman | Ph: 888-275-3853 | ||
| Ohio | |||
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| Akron | |||
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| Akron Children's Hospital | |||
| Steven J Kuerbitz | Ph: 330-543-3193 | ||
| Cincinnati | |||
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| Cincinnati Children's Hospital Medical Center | |||
| John P Perentesis | Ph: 513-636-2799 | ||
| Cleveland | |||
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| Cleveland Clinic Taussig Cancer Center | |||
| Tanya M Tekautz | Ph: 866-223-8100 | ||
| Seidman Cancer Center at University Hospitals/Case Medical Center | |||
| Yousif (Joe) H Matloub | Ph: 216-844-5437 | ||
| Columbus | |||
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| Nationwide Children's Hospital | |||
| Mark A Ranalli | Ph: 614-722-2708 | ||
| Dayton | |||
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| Dayton Children's - Dayton | |||
| Emmett H Broxson | Ph: 800-228-4055 | ||
| Oklahoma | |||
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| Oklahoma City | |||
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| Oklahoma University Cancer Institute | |||
| Rene Y McNall-Knapp | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Pennsylvania | |||
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| Danville | |||
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| Geisinger Cancer Institute at Geisinger Health | |||
| Jeffrey S Taylor | Ph: 570-271-5251 | ||
| Philadelphia | |||
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| Children's Hospital of Philadelphia | |||
| Tammy I Kang | Ph: 215-590-2810 | ||
| Pittsburgh | |||
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| Children's Hospital of Pittsburgh of UPMC | |||
| Arthur K Ritchey | Ph: 412-692-5573 | ||
| South Carolina | |||
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| Columbia | |||
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| Palmetto Health South Carolina Cancer Center | |||
| Ronnie W. Neuberg | Ph: 803-434-3680 | ||
| Greenville | |||
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| BI-LO Charities Children's Cancer Center | |||
| Nichole L Bryant | Ph: 864-241-6251 | ||
| Cancer Centers of the Carolinas - Faris Road | |||
| Nichole L Bryant | Ph: 864-241-6251 | ||
| Tennessee | |||
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| Memphis | |||
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| St. Jude Children's Research Hospital | |||
| Lisa M McGregor | Ph: 901-595-4644 | ||
| Texas | |||
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| Corpus Christi | |||
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| Driscoll Children's Hospital | |||
| M. C Johnson | Ph: 361-694-5311 | ||
| Dallas | |||
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| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||
| Naomi J Winick | Ph: 214-648-7097 | ||
| Fort Worth | |||
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| Cook Children's Medical Center - Fort Worth | |||
| Mary Meaghan P Granger | Ph: 682-885-2103 | ||
| Houston | |||
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| Dan L. Duncan Cancer Center at Baylor College of Medicine | |||
| Lisa R Bomgaars | Ph: 713-798-1354 | ||
| Email: burton@bcm.edu | |||
| San Antonio | |||
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| Methodist Children's Hospital of South Texas | |||
| Jaime Estrada | Ph: 210-575-7000 | ||
| University of Texas Health Science Center at San Antonio | |||
| Anne-Marie R Langevin | Ph: 210-567-0653 | ||
| Email: che@uthscsa.edu | |||
| Utah | |||
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| Salt Lake City | |||
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| Primary Children's Medical Center | |||
| Phillip E Barnette | Ph: 801-585-5270 | ||
| Vermont | |||
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| Burlington | |||
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| Vermont Cancer Center at University of Vermont | |||
| Alan C Homans | Ph: 802-656-8990 | ||
| Virginia | |||
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| Charlottesville | |||
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| University of Virginia Cancer Center | |||
| Kimberly P Dunsmore | Ph: 434-243-6143 | ||
| Norfolk | |||
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| Children's Hospital of The King's Daughters | |||
| Eric J Lowe | Ph: 757-668-7243 | ||
| Washington | |||
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| Seattle | |||
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| Children's Hospital and Regional Medical Center - Seattle | |||
| Douglas S Hawkins | Ph: 866-987-2000 | ||
| West Virginia | |||
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| Charleston | |||
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| West Virginia University Medical School - Charleston | |||
| Allen R Chauvenet | Ph: 304-388-9944 | ||
| Wisconsin | |||
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| Milwaukee | |||
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| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |||
| Michael E Kelly | Ph: 414-805-4380 | ||
| Australia | |||
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| Western Australia | |||
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| Perth | |||
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| Princess Margaret Hospital for Children | |||
| Catherine H Cole | Ph: (08) 9340 8330 | ||
| Email: admin@childcancerresearch.com.au | |||
| Canada | |||
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| Alberta | |||
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| Calgary | |||
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| Alberta Children's Hospital | |||
| Douglas R Strother | Ph: 403-220-6898 | ||
| Email: research4kids@ucalgary.ca | |||
| Nova Scotia | |||
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| Halifax | |||
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| IWK Health Centre | |||
| Margaret C Yhap | Ph: 902-470-8394 | ||
| Ontario | |||
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| Hamilton | |||
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| McMaster Children's Hospital at Hamilton Health Sciences | |||
| Carol Portwine | Ph: 905-521-2100ext74595 | ||
| Carol Portwine | Ph: 905-521-2100ext74595 | ||
| Toronto | |||
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| Hospital for Sick Children | |||
| David Malkin | Ph: 416-813-7654ext2027 | ||
| Email: jason.mcguire@sickkids.ca | |||
| Quebec | |||
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| Montreal | |||
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| Hopital Sainte Justine | |||
| Yvan Samson | Ph: 514-345-4931 | ||
| Ste-Foy | |||
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| Centre de Recherche du Centre Hospitalier de l'Universite Laval | |||
| Bruno Michon | Ph: 418-525-4444 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00304070
Information obtained from ClinicalTrials.gov on November 25, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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