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| Sponsor: | Pediatric Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002912 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may reduce resistance to the drug and allow more cancer cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of PSC-833 plus etoposide and mitoxantrone in treating children who have refractory or relapsed acute leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: etoposide Drug: mitoxantrone hydrochloride Drug: valspodar |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PHASE I COOPERATIVE AGREEMENT PEDIATRIC TRIAL OF MITOXANTRONE, ETOPOSIDE AND PSC-833 (PSC-ME) THERAPY IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE LEUKEMIA |
| Study Start Date: | January 1997 |
OBJECTIVES: I. Determine the maximum tolerated dose of PSC-833 in combination with mitoxantrone and etoposide in children with refractory or relapsed acute leukemia. II. Determine the effects of PSC-833 on mitoxantrone and etoposide pharmacokinetics. III. Quantify MDR1 gene expression and MDR1 P-glycoprotein expression and function in patient-derived leukemia cells.
OUTLINE: This is a dose escalation study of PSC-833. Patients undergo induction therapy consisting of etoposide IV and mitoxantrone IV on days 1-5. Patients then receive PSC-833 IV over 124 hours beginning on day 2. A second course is administered no sooner than 21 days from the start of the first course if the marrow is hypocellular after the first course. Patients with persistent disease after 2 induction courses are removed from the study. Patients receive a total of 3 courses of etoposide/mitoxantrone. Patients who achieve complete remission after 1 induction course receive 2 courses of etoposide/mitoxantrone with PSC-833 as consolidation, beginning within 4 weeks of attainment of complete remission. Patients who achieve complete remission after 2 induction courses receive 1 course of etoposide/mitoxantrone with PSC-833 as consolidation. Cohorts of 3-6 patients receive escalating doses of PSC-833 until the maximum tolerated dose is determined. Patients are followed every 6 months.
PROJECTED ACCRUAL: At least 3 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Hematologic malignancies as follows: Acute myeloid leukemia (AML) in one of the following categories: First relapse if initial CR less than 6 months Refractory to first or second induction with daunomycin, cytarabine, and thioguanine (DAT) or other anthracycline-containing regimens Relapse following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant Presentation with secondary AML or AML evolving from myelodysplastic syndrome Acute lymphocytic leukemia in one of the following categories: In second or subsequent relapse or failed second or later induction attempts regardless of prior remissions Relapsed following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant No isolated CNS or extramedullary relapse
PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100% (ECOG 0-2) Lansky 40-100% (in patients under 12 years of age) Life expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL ALT less than twice normal Renal: Creatinine normal for age (within 2 standard deviations) OR Glomular filtration rate at least 70 mL/min Albumin at least 3 g/dL Cardiovascular: Ejection fraction greater than 50% at rest or with 5% increase with exercise OR Shortening fraction greater than 27% by echocardiogram No history of clinical heart failure Other: No uncontrolled infection No anticonvulsant therapy No history of allergic reactions or anaphylaxis to etoposide not remediable by premedication Not pregnant or nursing Fertile patients must use effective contraception Third percentile weight for height
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy and recovered Prior cumulative anthracycline dose no greater than 360 mg per square meter Hydroxyurea therapy allowed just prior to study for rapidly rising blast count Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92668 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| City of Hope National Medical Center | |
| Los Angeles, California, United States, 91010 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Florida | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Boston Floating Hospital Infants and Children | |
| Boston, Massachusetts, United States, 02111 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Columbia Presbyterian Hospital | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Children's Hospital of Columbus | |
| Columbus, Ohio, United States, 43205-2696 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| Vanderbilt Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States, 77030-2399 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Study Chair: | Gary V.H. Dahl, MD | Lucile Packard Children's Hospital at Stanford University Medical Center |
More Information
| Study ID Numbers: | CDR0000065285, POG-9423, CCG-P9423 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002912 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia |
|
Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Etoposide phosphate Pharmacologic Actions Leukemia Neoplasms Sensory System Agents |
Therapeutic Uses Mitoxantrone Analgesics Peripheral Nervous System Agents Central Nervous System Agents Etoposide Antineoplastic Agents, Phytogenic |
