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Phase III Randomized Study of Continuous-Infusion vs Bolus High-Dose ARA-C During Induction and of Intensification with VP-16/IFF vs No Intensification in Children and Adolescents with Stage III/IV Diffuse Undifferentiated non-Hodgkin's Lymphoma or B-Cell ALL

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Chemotherapy in Young Patients With Non-Hodgkin's Lymphoma or Advanced B-cell Acute Lymphocytic Leukemia

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed21 and underNCIPOG-9317

Objectives

I.  Evaluate the efficacy of intensification chemotherapy with 
etoposide/ifosfamide vs. no intensification for patients with stage III/IV 
diffuse undifferentiated non-Hodgkin's lymphoma or advanced B-cell acute 
lymphocytic leukemia.

II.  Compare the toxicity and efficacy of high-dose cytarabine administered q 
12 hours x 4 vs. by 48-hour infusion in the induction regimen.

Entry Criteria

Disease Characteristics:


Advanced B-cell malignancy of one of the following types:
  Diffuse undifferentiated non-Hodgkin's lymphoma (DUL)
     Burkitt's or non-Burkitt's
     Murphy's stage III/IV
     At least 25% blasts in marrow considered B-cell acute lymphocytic
        leukemia (ALL)
     ALL with L3 morphology

Histologic/cytologic diagnosis by one of the following:
  Biopsy of mass
  Pleural, ascitic, or spinal fluid evaluation
  Bone marrow evaluation

Concurrent registration on protocol POG-9400 required for patients with ALL


Prior/Concurrent Therapy:


No prior therapy except surgery


Patient Characteristics:


Age:
  No more than 21

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  HIV-positive patients eligible
  No pregnant women


Expected Enrollment

340 patients will be accrued over an anticipated 6.2 years.

Outline

Randomized study.  At registration, all patients are randomized to Arms I and 
II for Induction, and patients without CNS disease are randomized to Arms III 
and IV for Intensification (those who present with CNS disease are nonrandomly 
assigned to Intensification Arm III).  Following Intensification, patients 
with Stage III lymphoma (DUL) proceed to Regimen A for Consolidation while 
those with Stage IV DUL or ALL proceed to Regimen B.

Induction.

Arm I (Bolus ARA-C):  PHASE 1:  3-Drug Combination Systemic Chemotherapy with 
Urothelial Protection and Hematologic Toxicity Attenuation plus 2-Drug 
Intrathecal Chemotherapy with Leucovorin Rescue followed by PHASE 2:  2-Drug 
Combination Systemic Chemotherapy with Leucovorin Rescue and Hematologic 
Toxicity Attenuation plus Single-Agent Intrathecal Chemotherapy.  PHASE 1:  
Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Vincristine, 
VCR, NSC-67574; with Mesna, NSC-113891; and Granulocyte Colony-Stimulating 
Factor (Amgen), G-CSF, NSC-614629; plus Intrathecal Methotrexate, IT MTX, 
NSC-740; Intrathecal Cytarabine, IT ARA-C, NSC-63878; with Leucovorin calcium, 
CF, NSC-3590; followed by PHASE 2:  MTX; ARA-C; with CF; and G-CSF; plus IT 
MTX.

Arm II (Continuous-Infusion ARA-C):  PHASE 1:  3-Drug Combination Systemic 
Chemotherapy with Urothelial Protection and Hematologic Toxicity Attenuation 
plus 2-Drug Intrathecal Chemotherapy with Leucovorin Rescue followed by PHASE 
2:  2-Drug Combination Systemic Chemotherapy with Leucovorin Rescue and 
Hematologic Toxicity Attenuation plus Single-Agent Intrathecal Chemotherapy.  
PHASE 1:  CTX; DOX; VCR; with Mesna; and G-CSF; plus IT MTX; IT ARA-C; with 
CF; followed by PHASE 2:  MTX; ARA-C; with CF; and G-CSF; plus IT MTX.

Intensification.

Arm III:  2-Drug Combination Systemic Chemotherapy with Urothelial Protection 
and Hematologic Toxicity Attenuation plus 2-Drug Intrathecal Chemotherapy.  
Etoposide, VP-16, NSC-141540; Ifosfamide, IFF, NSC-109724; with Mesna; and 
G-CSF; plus IT MTX; IT ARA-C.

Arm IV:  No therapy.

Consolidation.

Regimen A (Stage III DUL):  PHASE 1:  2-Drug Combination Systemic Chemotherapy 
with Urothelial Protection plus 2-Drug Intrathecal Chemotherapy alternating 
with PHASE 2:  2-Drug Combination Systemic Chemotherapy with Leucovorin Rescue 
and Hematologic Toxicity Attenuation plus Single-Agent Intrathecal 
Chemotherapy.  PHASE 1:  CTX; VCR; with Mesna; plus IT MTX; IT ARA-C; followed 
by PHASE 2:  MTX; ARA-C; with CF; and G-CSF; plus IT MTX; followed by PHASE 1.

Regimen B (Stage IV DUL and ALL):  PHASE 1:  3-Drug Combination Systemic 
Chemotherapy with Urothelial Protection and Hematologic Toxicity Attenuation 
plus 2-Drug Intrathecal Chemotherapy with Leucovorin Rescue alternating with 
PHASE 2:  2-Drug Combination Systemic Chemotherapy with Leucovorin Rescue and 
Hematologic Toxicity Attenuation plus Single-Agent Intrathecal Chemotherapy.  
PHASE 1:  CTX; DOX; VCR; with Mesna; and G-CSF; plus IT MTX; IT ARA-C; with 
CF; followed by PHASE 2:  MTX; ARA-C; with CF; and G-CSF; plus IT MTX; 
followed by PHASE 1; followed by PHASE 2.

Published Results

Schwenn MR, Mahmoud HH, Bowman WP, et al.: Successful treatment of small noncleaved cell (SNCC) lymphoma and B cell acute lymphoblastic leukemia (B-ALL) with central nervous system (CNS) involvement: a Pediatric Oncology Group (POG) Study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2282, 2000.

Schwenn MR, Bowman WP, Shuster J: Equivalent tolerance of high-dose cytosine arabinoside (HD Ara-C) by bolus versus continuous infusion (CI) in a randomized trial for B-cell acute lymphoblastic leukemia (B-ALL) and diffuse undifferentiated lymphoma (DUL). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1294, 409, 1995.

Related Publications

Hutchison RE, Finch C, Kepner J, et al.: Burkitt lymphoma is immunophenotypically different from Burkitt-like lymphoma in young persons. Ann Oncol 11 (Suppl 1): 35-8, 2000.[PUBMED Abstract]

Schwenn M, Laver J: Effective use of G-CSF with an early stop rule in intensive Pediatric Oncology Group (POG) protocols for B-cell lymphoma/leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-1568, 453, 1994.

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Molly Schwenn, MD, Protocol chair
Ph: 508-856-4225

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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