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A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)


Phase 2
16 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)


OBJECTIVES:

- Assess the complete remission rate in patients with recurrent or refractory non-T-cell
acute lymphocytic leukemia when treated with 506U78.

- Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21
days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6
months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphocytic leukemia (ALL)

- FAB class L1-L2

- Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in
peripheral blood, bone marrow, or in at least 1 extramedullary disease site)

- Coexpression of myeloid antigens CD13 or CD33 allowed

- Histologically confirmed extramedullary disease in the absence of bone marrow or
blood involvement allowed

- CD3 and myeloperoxidase marker negative

- Meeting 1 of the following criteria for recurrent/refractory disease:

- Refractory to standard induction regimen including at least vincristine and
prednisone

- Recurrence after response after prior induction therapy

- Recurrence and failure on subsequent treatment

- No CNS involvement

- Must be registered on SWOG-S9910 and SWOG-9007

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Zubrod 0-3

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 3 times ULN

Renal:

- Creatinine no greater than 2 times ULN

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No grade 2 or greater neuropathy

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other
adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

CR

Outcome Time Frame:

After induction therapy is completed

Safety Issue:

No

Principal Investigator

Steven E. Coutre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000068032

NCT ID:

NCT00006020

Start Date:

July 2000

Completion Date:

July 2004

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • non-T, non-B adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
MBCCOP - HawaiiHonolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Stanford UniversityStanford, California  94305
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
University of California Davis Cancer CenterSacramento, California  95817
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Oregon Cancer InstitutePortland, Oregon  97201-3098
Danville Radiation Therapy CenterMemphis, Tennessee  38104
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Barrett Cancer CenterCincinnati, Ohio  45267-0502
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Genesis Medical CenterDavenport, Iowa  52804