AzTrials
AzTrials

LymphomaPhase 2NCT00002590

Combination Chemotherapy in Treating Children With Lymphoma

A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Lymphoma, run by Children's Oncology Group at 33 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 20 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, cyclophosphamide and cytarabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
33 sitesin 3 countries
Study dates
Jul 1994to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

United States30 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Children's Hospital Medical Center - Cincinnati

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Children's Hospital of Columbus

    Columbus, Ohio, 43205-2696

  • Children's Hospital of Denver

    Denver, Colorado, 80218

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • Children's Hospital of Orange County

    Orange, California, 92668

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Doernbecher Children's Hospital

    Portland, Oregon, 97201-3098

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

Canada2 sites

  • IWK Grace Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

About this study

Official title: A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma

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.

Read the 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.

Conditions
Lymphoma
Being tested
filgrastim, cyclophosphamide, cytarabine, daunorubicin hydrochloride, doxorubicin hydrochloride
Keywords
stage IV childhood lymphoblastic lymphoma, stage IV childhood large cell lymphoma
Medical subject headings
Lymphoma, Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Also called G-CSF, Neupogen, NSC-614629

  • cyclophosphamideDrug

    Also called Cytoxan

  • cytarabineDrug

    Also called Cytosine Arabinoside, Ara-C, Cytosar-U, NSC-63878

  • daunorubicin hydrochlorideDrug

    Also called Daunomycin, Cerubidine

  • doxorubicin hydrochlorideDrug

    Also called Adriamycin, NSC-123127

  • etoposideDrug

    Also called VP-16, VePesid), NSC-141540

  • leucovorin calciumDrug

    Also called Citrovorum Factor, Folinic Acid

  • methotrexateDrug

  • pegaspargaseDrug

    Also called PEG Asparaginase, Oncaspar®

  • prednisoneDrug

    Also called NSC-10023

  • thioguanineDrug

    Also called 6-Thioguanine, 6-TG, NSC-752

  • vincristine sulfateDrug

    Also called Oncovin

  • radiation therapyRadiation

Study groups in NCT00002590
Study groupRoleWhat they receive
Regimen AExperimentalSee detailed description.
Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: leucovorin calcium; Drug: methotrexate; Drug: pegaspargase; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate toxicity and feasibility of 11 month multiagent chemotx

    Estimate the toxicity and feasibility of a short (11 month) aggressive multiagent chemotherapy regimen - Intensive NYI\NHL

Secondary outcomes (3)

  1. Provide preliminary data for a future phase III study

  2. Investigate the biology of lymphoblastic lymphoma

    To continue to investigate the biology of lymphoblastic lymphoma and its relationship to leukemia through the study of immunophenotyping, cytogenetics and molecular analysis.

  3. Obtain preliminary data on treatment of anaplastic large cell

    To obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2004 (estimated)
  2. Study startJul 1994
  3. Primary completionMar 2001
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002590
Sponsor's protocol ID
5941
Other IDs
CCG-5941, CDR0000063751
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
24 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11981000

  • 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.

    PubMed 18985718

  • 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.

    PubMed 18759768

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Lymphoma, run by Children's Oncology Group at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate toxicity and feasibility of 11 month multiagent chemotx. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002590, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in