Topotecan in Treating Children With Refractory Leukemia

NCT00002705 | Completed Phase 1

• 3 other identifiers: NCI-2012-01833POG-9575CDR0000064511
• Study Type: interventional
• Target: 3
• Locations: 4 countries
• Sites: 31

Brief Summary

Phase I trial to study the effectiveness of topotecan in treating children with refractory leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; relapsing chronic myelogenous leukemia

Study Arms (1)

Arm I

EXPERIMENTAL

Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.

Drug: topotecan hydrochloride

Interventions

topotecan hydrochloride DRUG

Arm I

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: -Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists PATIENT CHARACTERISTICS: * Age: Under 21 * Performance status: ECOG 0-2 * Life expectancy: At least 8 weeks * Adequate platelet count and hemoglobin required (transfusion allowed) * Bilirubin no greater than 1.5 mg/dL * AST or ALT no greater than 2 times normal * Creatinine less than 1.5 mg/dL * Adequate nutritional status, e.g. higher than third percentile weight for height * Albumin at least 3 g/dL * No severe uncontrolled infection * No pregnant women * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: * At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas) * Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation) * No concurrent anticancer therapy * No concurrent treatment studies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (31)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Boston Floating Hospital Infants and Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Memorial Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Furman WL, Stewart CF, Kirstein M, Kepner JL, Bernstein ML, Kung F, Vietti TJ, Steuber CP, Becton DL, Baruchel S, Pratt C. Protracted intermittent schedule of topotecan in children with refractory acute leukemia: a pediatric oncology group study. J Clin Oncol. 2002 Mar 15;20(6):1617-24. doi: 10.1200/JCO.2002.20.6.1617.

  PMID: 11896112 RESULT

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Wayne Lee Furman, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 1, 2004
• Study Start: April 1, 1996
• Primary Completion: January 1, 2001
• Last Updated: February 1, 2013

Record last verified: 2001-05

Locations

CA (2); PR (1); US (27); CH (1)