Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

Leukemia Clinical Trial

Official title:

Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003671
• Other study ID #: 9705
• Secondary ID: POG-9705CDR00000
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 24, 2014
• Start date: December 1998
• Est. completion date: February 2009

Study information

• Verified date: July 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Description:

OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.

OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2009
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy:

Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• asparaginase

• cyclophosphamide

• cytarabine

• daunorubicin hydrochloride

• dexamethasone

• leucovorin calcium

• mercaptopurine

• methotrexate

• thioguanine

• vincristine sulfate

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitalier de L'Universite Laval	Sainte Foy	Quebec
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Puerto Rico	San Jorge Childrens Hospital	Santurce
Switzerland	Clinique de Pediatrie	Geneva
United States	University of New Mexico School of Medicine	Albuquerque	New Mexico
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Vermont Cancer Center	Burlington	Vermont
United States	West Virginia University Medical School, Charleston Division	Charleston	West Virginia
United States	Children's Memorial Hospital, Chicago	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Missouri-Columbia Hospital and Clinics	Columbia	Missouri
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	St. John's Hospital and Medical Center	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Hurley Medical Center	Flint	Michigan
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	James H. Quillen College of Medicine	Johnson City	Tennessee
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Baptist Hospital of Miami	Miami	Florida
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Christ Hospital	Oak Lawn	Illinois
United States	Oklahoma Memorial Hospital	Oklahoma City	Oklahoma
United States	Walt Disney Memorial Cancer Institute	Orlando	Florida
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California
United States	Saint Jude Midwest Affiliate	Peoria	Illinois
United States	Maine Children's Cancer Program	Portland	Maine
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Sutter Cancer Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California
United States	Naval Medical Center - San Diego	San Diego	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Scott and White Clinic	Temple	Texas
United States	Arizona Cancer Center	Tucson	Arizona
United States	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	St. Mary's Hospital	West Palm Beach	Florida
United States	Via Christi Regional Medical Center-Saint Francis Campus	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Puerto Rico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival		7 years	No