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Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myelodysplastic Syndromes

Intervention: asparaginase (Drug); cytarabine (Drug); gemtuzumab ozogamicin (Drug); mitoxantrone hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Richard Aplenc, MD, MSCE, Study Chair, Affiliation: Children's Hospital of Philadelphia

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Clinical Details

Official title: A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study design: Primary Purpose: Treatment

Primary outcome: Event Free Survival

Secondary outcome:

Toxicity

Remission Rate

Prognostic Factor Analysis

Detailed description: OBJECTIVES:

- Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination

with conventional chemotherapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes.

- Determine the efficacy of this regimen in these patients.

- Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the

efficacy of this regimen in these patients.

- Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1

expression by leukemic blast cells with the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are assigned by cohort to 1 of 2 treatment regimens.

- Regimen A: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4,

mitoxantrone IV over 1 hour on days 3-6, and gemtuzumab ozogamicin IV over 2 hours on day 7.

- Regimen B: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8,

and 9, asparaginase intramuscularly on days 2 and 9, and gemtuzumab ozogamicin IV over 2 hours on day 3. Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1. 5 years.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes

- Relapsed (remission duration less than 1 year) OR

- Failed induction (failed to achieve an initial complete response)

- Patients with AML as a second malignant neoplasm allowed provided no other prior

therapy for AML

- M2 or M3 bone marrow aspirate at time of study entry

- No Fanconi's anemia

- No known CNS leukemia

PATIENT CHARACTERISTICS: Age:

- 21 and under

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1. 5 times normal

- AST or ALT less than 2. 5 times upper limit of normal

- No history of veno-occlusive disease of the liver defined as weight increase of more

than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after receipt of chemotherapy Renal:

- Creatinine no greater than 1. 5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70

mL/min OR

- Equivalent GFR by institutional normal range

Cardiovascular:

- Shortening fraction more than 27% by echocardiogram or normal for institution OR

- Ejection fraction more than 50% by MUGA

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy:

- At least 180 days since prior hematopoietic stem cell transplantation

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Locations and Contacts

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California 90801, United States

Children's Hospital Los Angeles, Los Angeles, California 90027, United States

Children's Hospital of Orange County, Orange, California 92868, United States

Children's Hospital and Health Center - San Diego, San Diego, California 92123-4282, United States

Stanford Cancer Center at Stanford University Medical Center, Stanford, California 94305, United States

Children's Hospital Cancer Center, Denver, Colorado 80218-1088, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0232, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida 32803-1273, 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

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 95813, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

St. Vincent Indianapolis Hospital, Indianapolis, Indiana 46260, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0084, United States

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine 04401, 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

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan 48109-0238, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

Children's Hospital of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States

Fairview University Medical Center - University Campus, Minneapolis, Minnesota 55455, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, 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

Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, 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

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, 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

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-5217, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States

Columbus Children's Hospital, Columbus, Ohio 43205-2696, United States

Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States

Tod Children's Hospital - Forum Health, Youngstown, Ohio 44501, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

McGill Cancer Centre at McGill University, Montreal, Quebec H3H 1P3, Canada

Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec G1V 4G2, Canada

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States

Greenville Hospital System Cancer Center, Greenville, South Carolina 29605, 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, Texas 79106, United States

Children's Hospital of Austin, Austin, Texas 78701, 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

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia 23298-0037, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington 99220-2555, United States

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia 25701, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2002
Last updated: February 18, 2014

Page last updated: August 23, 2015

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