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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003545
Other study ID # NCI-2012-01840
Secondary ID CLB-19801SWOG-C1
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated February 4, 2013
Start date August 1998

Study information

Verified date April 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.


Description:

OBJECTIVES:

I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).

II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.

OUTLINE:

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)

- Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8

- Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13

- Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission

- No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy

PATIENT CHARACTERISTICS:

- Age: 16 and over

- Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)

- Creatinine clearance at least 50 mL/min (unless due to leukemia)

- No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL

- No preexisting neuropathy of grade 2 or greater regardless of causality

- No history of seizure disorder

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No concurrent erythropoietin

- No other concurrent chemotherapy

- No concurrent dexamethasone or other steroidal antiemetics

- No concurrent hormone therapy, except for non-disease-related conditions

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
nelarabine


Locations

Country Name City State
United States MBCCOP - University of New Mexico HSC Albuquerque New Mexico
United States Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico
United States CCOP - Ann Arbor Regional Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan
United States CCOP - Atlanta Regional Atlanta Georgia
United States CCOP - Montana Cancer Consortium Billings Montana
United States Veterans Affairs Medical Center - Biloxi Biloxi Mississippi
United States Boston Medical Center Boston Massachusetts
United States MBCCOP - University of Illinois at Chicago Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States CCOP - Columbus Columbus Ohio
United States Simmons Cancer Center - Dallas Dallas Texas
United States Veterans Affairs Medical Center - Dayton Dayton Ohio
United States CCOP - Central Illinois Decatur Illinois
United States University of Colorado Cancer Center Denver Colorado
United States Veterans Affairs Medical Center - Denver Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Veterans Affairs Medical Center - Detroit Detroit Michigan
United States Cancer Center and Beckman Research Institute, City of Hope Duarte California
United States CCOP - Duluth Duluth Minnesota
United States Dwight David Eisenhower Army Medical Center Fort Gordon Georgia
United States Brooke Army Medical Center Fort Sam Houston Texas
United States University of Texas Medical Branch Galveston Texas
United States CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States CCOP - Greenville Greenville South Carolina
United States Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States University of Mississippi Medical Center Jackson Mississippi
United States Veterans Affairs Medical Center - Jackson Jackson Mississippi
United States Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts
United States CCOP - Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Veterans Affairs Medical Center - Kansas City Kansas City Missouri
United States Keesler Medical Center - Keesler AFB Keesler AFB Mississippi
United States CCOP - Dayton Kettering Ohio
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Veterans Affairs Medical Center - Lexington Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas
United States Veterans Affairs Medical Center - Long Beach Long Beach California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States Veterans Affairs Medical Center - West Los Angeles Los Angeles California
United States Texas Tech University Health Science Center Lubbock Texas
United States Veterans Affairs Outpatient Clinic - Martinez Martinez California
United States Loyola University Medical Center Maywood Illinois
United States MBCCOP - Gulf Coast Mobile Alabama
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center New York New York
United States CCOP - Bay Area Tumor Institute Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States CCOP - Greater Phoenix Phoenix Arizona
United States Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona
United States CCOP - Columbia River Program Portland Oregon
United States Oregon Cancer Center Portland Oregon
United States Veterans Affairs Medical Center - Portland Portland Oregon
United States University of California Davis Medical Center Sacramento California
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas
United States CCOP - Santa Rosa Memorial Hospital Santa Rosa California
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Swedish Cancer Institute Seattle Washington
United States Veterans Affairs Medical Center - Seattle Seattle Washington
United States Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana
United States Veterans Affairs Medical Center - Shreveport Shreveport Louisiana
United States Providence Hospital - Southfield Southfield Michigan
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Stanford University Stanford California
United States CCOP - Northwest Tacoma Washington
United States Madigan Army Medical Center Tacoma Washington
United States CCOP - Scott and White Hospital Temple Texas
United States Veterans Affairs Medical Center - Temple Temple Texas
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States David Grant Medical Center Travis Air Force Base California
United States Arizona Cancer Center Tucson Arizona
United States Veterans Affairs Medical Center - Tucson Tucson Arizona
United States CCOP - Wichita Wichita Kansas
United States Veterans Affairs Medical Center - Wichita Wichita Kansas
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Southwest Oncology Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

De Angelo DJ, Yu D, Dodge RK, et al.: A phase II study of 2-amino-9-b-D-arabinosyl-6-methoxy-9H-purine (506U78) in patients with relapsed or refractory T-Lineage acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL): CALGB study 19801. [Abstr

DeAngelo DJ, Yu D, Johnson JL, Coutre SE, Stone RM, Stopeck AT, Gockerman JP, Mitchell BS, Appelbaum FR, Larson RA. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lympho — View Citation

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