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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006008 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: arsenic trioxide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia |
| Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Morphologically proven acute lymphoblastic leukemia (ALL)
Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, California | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Veterans Affairs Medical Center - Palo Alto | |
| Palo Alto, California, United States, 94304 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Inc. | |
| Denver, Colorado, United States, 80209-5031 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Veterans Affairs Medical Center - Gainsville | |
| Gainesville, Florida, United States, 32608-1197 | |
| Veterans Affairs Medical Center - Miami | |
| Miami, Florida, United States, 33125 | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Holden Comprehensive Cancer Center at The University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| Veterans Affairs Medical Center - Omaha | |
| Omaha, Nebraska, United States, 68105 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Veterans Affairs Medical Center - Brooklyn | |
| Brooklyn, New York, United States, 11209 | |
| Veterans Affairs Medical Center - New York | |
| New York, New York, United States, 10010 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Veterans Affairs Medical Center - Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Veterans Affairs Medical Center - Madison | |
| Madison, Wisconsin, United States, 53705 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Veterans Affairs Medical Center - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| South Africa | |
| Pretoria Academic Hospitals | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | Mark R. Litzow, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000068016, E-9998 |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006008 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult acute lymphoblastic leukemia L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia L3 adult acute lymphoblastic leukemia |
|
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Arsenic trioxide |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders |
