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Phase 2
20 Years
Not Enrolling

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Trial Information



I. Determine the efficacy and toxicity of intensified systemic treatment with delayed
central nervous system (CNS) irradiation in children with acute lymphoblastic leukemia and
isolated CNS disease.

II. Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the
cerebrospinal fluid of these patients.

III. Evaluate the toxicity of single dose thiotepa followed by dexamethasone, vincristine,
daunorubicin, and triple intrathecal therapy in these patients.

IV. Determine the response rate of intrathecal sustained release cytarabine (DTC101) in
patients with first bone marrow remission with first isolated CNS relapse.

V. Assess the safety and toxicity of DTC101 in these patients.


Patients with significant neurologic symptoms (e.g., seizures, cranial nerve palsy, paresis,
mental status changes) are entered directly on the Induction regimen and do not receive the
Therapeutic Window. The following acronyms are used: ARA-C Cytarabine, NSC-63878 ASP
Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia) CF Leucovorin calcium, NSC-3590 CTX
Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DNR Daunorubicin, NSC-82151 DTC101
Sustained release cytarabine G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629
HC Hydrocortisone, NSC-10483 Mesna Mercaptoethane sulfonate, NSC-113891 MP Mercaptopurine,
NSC-755 MTX Methotrexate, NSC-740 TIT Triple Intrathecal Therapy, IT MTX/IT HC/IT ARA-C
TMP-SMX Trimethoprim-sulfamethoxazole TSPA Thiotepa, NSC-6396 VCR Vincristine, NSC-67574
VP-16 Etoposide, NSC-141540

THERAPEUTIC WINDOW: Single Agent Chemotherapy. TSPA or DTC101. ** Thiotepa window closed as
of 7/6/98 ** ** DTC101 window opened 11/15/99 **

INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus

CONSOLIDATION: 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP;
plus TIT.

INTENSIFICATION I: 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple
Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT.

RE-INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR;
plus TIT.

INTENSIFICATION II: 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple
Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT.

CHEMORADIOTHERAPY: Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal
irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord
irradiation); plus ASP/DM/VCR.

MAINTENANCE: 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination
Chemotherapy. MP/MTX; alternating with CTX/VCR.

Inclusion Criteria


- Acute lymphoblastic leukemia in first bone marrow remission (M1) with first isolated
initial CNS relapse

- More than 5 WBC/microliter in cerebrospinal fluid (CSF) with blasts on cytospin OR
immunophenotypic proof (encouraged) of relapse in CSF

- Identifiable blasts and presence on 2 CSF samples 3 weeks apart

- If B-cell terminal deoxynucleotidyl transferase (TdT) OR CD-10

- If T-cell TdT alone OR with CD-7


- Age: Over 6 months and under 21 years at relapse

- Patients receiving sustained release cytarabine

- Performance status: Older than 10 years

- Karnofsky greater than 50% Less than 10 years

- Lansky greater than 50%

- Platelet count greater than 40,000/mm3

- Bilirubin less than 2.0 mg/dL

- SGPT less than 5 times normal

- Creatinine less than 1.5 times normal for age

- Normal metabolic parameters (serum electrolytes, calcium, and phosphorus)

- No clinical evidence of obstructive hydrocephalus, compartmentalization of the CSF
flow, ventriculoperitoneal or ventriculoatrial shunt


- Prior cumulative anthracycline dose less than 375 mg/sqm

- Patients receiving sustained release cytarabine

- At least 7 days since prior investigational drug

- At least 3 weeks since prior CNS directed therapy (6 weeks is prior nitrosourea)

- At least 1 week since intrathecal chemotherapy

- At least 8 weeks since prior craniospinal radiotherapy

Type of Study:


Study Design:

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

Principal Investigator

Julio C. Barredo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Food and Drug Administration

Study ID:




Start Date:

January 1996

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • T-cell childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • TdT positive childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Baylor College of Medicine Houston, Texas  77030
Roswell Park Cancer Institute Buffalo, New York  14263
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of California Davis Medical Center Sacramento, California  95817
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Florida Pediatric Tampa, Florida  33682-7757
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
Children's Hospital of Michigan Detroit, Michigan  48201
Mount Sinai School of Medicine New York, New York  10029
Memorial Mission Hospital Asheville, North Carolina  28801
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Oklahoma Memorial Hospital Oklahoma City, Oklahoma  73126-0307
Rhode Island Hospital Providence, Rhode Island  02903
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Ochsner New Orleans, Louisiana  70121
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
MBCCOP - University of South Alabama Mobile, Alabama  36688
Tulane University School of Medicine New Orleans, Louisiana  70112
CCOP - Columbia River Program Portland, Oregon  97213
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Hackensack University Medical Center Hackensack, New Jersey  07601
Miami Children's Hospital Miami, Florida  33155-4069
Via Christi Regional Medical Center Wichita, Kansas  67214
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
Carolinas Medical Center Charlotte, North Carolina  28232-2861
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Children's Hospital and Health Center San Diego, California  92123-4282
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
MBCCOP - South Texas Pediatric San Antonio, Texas  78284-7810