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NCT00002590 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Children With Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-07-24

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed and previously untreated anaplastic large cell Ki-1 lymphoma and T-cell large cell lymphoma Malignant lymphoblasts (identified by immunophenotype) in pleural fluid, ascitic fluid, or bone marrow sufficient for diagnosis Large cell lymphoma with T-cell phenotype eligible Localized mediastinal disease and bone lymphoma eligible CNS disease eligible and defined as: Any clearly identifiable tumor cells in cerebral spinal fluid Cranial nerve palsy (if not explained by extra cranial tumor) Clinical Spinal Cord Compression Isolated intra cerebral mass No cranial nerve palsies requiring immediate CNS irradiation PATIENT CHARACTERISTICS: Age: Under 21 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Shortening fraction greater than 27% on echocardiogram (ECHO) OR Left ventricular ejection fraction greater than 47% on radionuclide scan (RCNA) OR Cardiac function assessed as within normal limits by cardiologist ECHO or RCNA obtained as close as clinically possible to start of therapy PRIOR CONCURRENT THERAPY: No prior therapy except emergency treatment of airway obstruction or superior vena cava syndrome No more than 72 hours between emergency radiotherapy or steroids and initiation of protocol therapy
healthy Volunteers
false
maximum Age
20 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    See detailed description.
    intervention Names
    1. Biological: filgrastim
    2. Drug: cyclophosphamide
    3. Drug: cytarabine
    4. Drug: daunorubicin hydrochloride
    5. Drug: doxorubicin hydrochloride
    6. Drug: etoposide
    7. Drug: leucovorin calcium
    8. Drug: methotrexate
    9. Drug: pegaspargase
    10. Drug: prednisone
    11. Drug: thioguanine
    12. Drug: vincristine sulfate
    label
    Regimen A
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen A
    name
    filgrastim
    other Names
    1. G-CSF
    2. Neupogen
    3. NSC-614629
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Regimen A
    name
    cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  3. arm Group Labels
    1. Regimen A
    name
    cytarabine
    other Names
    1. Cytosine Arabinoside
    2. Ara-C
    3. Cytosar-U
    4. NSC-63878
    type
    DRUG
  4. arm Group Labels
    1. Regimen A
    name
    daunorubicin hydrochloride
    other Names
    1. Daunomycin
    2. Cerubidine
    type
    DRUG
  5. arm Group Labels
    1. Regimen A
    name
    doxorubicin hydrochloride
    other Names
    1. Adriamycin
    2. NSC-123127
    type
    DRUG
  6. arm Group Labels
    1. Regimen A
    name
    etoposide
    other Names
    1. VP-16
    2. VePesid)
    3. NSC-141540
    type
    DRUG
  7. arm Group Labels
    1. Regimen A
    name
    leucovorin calcium
    other Names
    1. Citrovorum Factor
    2. Folinic Acid
    type
    DRUG
  8. arm Group Labels
    1. Regimen A
    name
    methotrexate
    type
    DRUG
  9. arm Group Labels
    1. Regimen A
    name
    pegaspargase
    other Names
    1. PEG Asparaginase
    2. Oncaspar®
    type
    DRUG
  10. arm Group Labels
    1. Regimen A
    name
    prednisone
    other Names
    1. NSC-10023
    type
    DRUG
  11. arm Group Labels
    1. Regimen A
    name
    thioguanine
    other Names
    1. 6-Thioguanine
    2. 6-TG
    3. NSC-752
    type
    DRUG
  12. arm Group Labels
    1. Regimen A
    name
    vincristine sulfate
    other Names
    1. Oncovin
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
221
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Estimate the toxicity and feasibility of a short (11 month) aggressive multiagent chemotherapy regimen - Intensive NYI\\NHL
    measure
    Estimate toxicity and feasibility of 11 month multiagent chemotx
secondary Outcomes
  1. measure
    Provide preliminary data for a future phase III study
  2. description
    To continue to investigate the biology of lymphoblastic lymphoma and its relationship to leukemia through the study of immunophenotyping, cytogenetics and molecular analysis.
    measure
    Investigate the biology of lymphoblastic lymphoma
  3. description
    To obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI.
    measure
    Obtain preliminary data on treatment of anaplastic large cell
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
detailed Description
OBJECTIVES: I. Estimate the toxicity and feasibility of intensifying the New York I (NYI) regimen by adding etoposide and cytarabine, increasing the dose of methotrexate, using pegaspargase, and compressing the treatment duration (11 months) in previously untreated children with disseminated anaplastic (Ki-1 positive) large cell and large cell T-cell lymphoma. II. Provide preliminary data for a future phase III study that will compare this intensified regimen with the high-risk ALL regimen NYI in children with disseminated lymphoblastic lymphoma. III. Continue to investigate the immunophenotype, cytogenetics, and molecular biology of lymphoblastic lymphoma and their relationship to leukemia. IV. Obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI. OUTLINE: Patients with CNS disease at diagnosis receive craniospinal irradiation on Regimen A at the conclusion of Maintenance chemotherapy. The following acronyms are used: ARA-C Cytarabine, NSC-63878 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DNR Daunorubicin, NSC-82151 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 MTX Methotrexate, NSC-740 PEG-ASP Pegaspargase, NSC-624239 PRED Prednisone, NSC-10023 TG Thioguanine, NSC-752 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Induction: 5-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus 2-Drug Combination Intrathecal Chemotherapy. VCR/PRED/CTX/DNR/PEG-ASP; with G-CSF; plus IT ARA-C/IT MTX. Consolidation: 7-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy. VCR/PRED/PEG-ASP/VP-16/TG/ARA-C/MTX/CF; with G-CSF; plus IT MTX. Maintenance: Sequential Pulses of 2-, 3-, 3-, and 2-Drug Systemic Chemotherapy Combinations plus Single-Agent Intrathecal Chemotherapy. CTX/TG/IT MTX; VCR/PRED/DOX; VCR/MTX/CF/PEG-ASP; ARA-C/VP-16. Regimen A: Radiotherapy. Craniospinal irradiation using megavoltage equipment. PROJECTED ACCRUAL: 40 patients will be entered over approximately 10 months. If 4 or more toxic deaths occur in the first 15 patients or 5 or more toxic deaths occur in the first 30 patients, accrual will stop. As of 05/96, asparaginase has been replaced with pegaspargase; 15-25 additional patients will be accrued. As of 01/97, a maximum of 35 patients will be accrued for PEG asparaginase-containing treatment regimen. As of 5/97, this study is open only to patients with anaplastic large cell and T cell large cell lymphoma. Approximately 60-90 patients will be accrued.
Source references
references
  1. citation
    Lones MA, Perkins SL, Sposto R, Tedeschi N, Kadin ME, Kjeldsberg CR, Wilson JF, Zwick DL, Cairo MS. Non-Hodgkin's lymphoma arising in bone in children and adolescents is associated with an excellent outcome: a Children's Cancer Group report. J Clin Oncol. 2002 May 1;20(9):2293-301. doi: 10.1200/JCO.2002.06.017.
    pmid
    11981000
    type
    BACKGROUND
  2. citation
    Lowe EJ, Sposto R, Perkins SL, Gross TG, Finlay J, Zwick D, Abromowitch M; Children's Cancer Group Study 5941. Intensive chemotherapy for systemic anaplastic large cell lymphoma in children and adolescents: final results of Children's Cancer Group Study 5941. Pediatr Blood Cancer. 2009 Mar;52(3):335-9. doi: 10.1002/pbc.21817.
    pmid
    18985718
    type
    RESULT
  3. citation
    Abromowitch M, Sposto R, Perkins S, Zwick D, Siegel S, Finlay J, Cairo MS; Children's Oncology Group. Shortened intensified multi-agent chemotherapy and non-cross resistant maintenance therapy for advanced lymphoblastic lymphoma in children and adolescents: report from the Children's Oncology Group. Br J Haematol. 2008 Oct;143(2):261-7. doi: 10.1111/j.1365-2141.2008.07320.x. Epub 2008 Aug 28.
    pmid
    18759768
    type
    RESULT
  4. citation
    Abromowitch M, Sposto R, Perkins S, et al.: Outcome of Children's Cancer Group (CCG) 5941: a pilot study for the treatment of newly diagnosed pediatric patients with disseminated lymphoblastic lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2295, 2000.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        actors, the clinical risk features were not found to be significant.[<a href="#cit/section_1.54">54</a>] In the <a href="/clinicaltrials/NCT00002590">CCG-5941 (NCT00002590)</a> study for patients with anaplastic large cell lymphoma, these clinical risk factors could not be confirmed. Only bone marrow involvement predicted inferio
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        egimens, although the duration of first remission was prolonged by the longer therapy.[<a href="#cit/section_8.17">17</a>]</li><li>The <a href="/clinicaltrials/NCT00002590">CCG-5941</a> study tested an approach similar to that used in the LNH-92 trial, with more intensive induction and consolidation with maintenance for a total d
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      source update dates
      1. context
        Updated: April 17, 2025
        datetime
        2025-04-17T12:00:00Z
        display
        April 17, 2025

    Preserved source evidence · Not medical advice