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LymphomaPhase 2NCT00070304

Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma

A Phase 2 study testing filgrastim, gemcitabine hydrochloride and vinorelbine tartrate in people with Lymphoma, run by Children's Oncology Group at 123 sites in 5 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, such as gemcitabine and vinorelbine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Read more about this study

Who is it for?
Ages Up to 30 years
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, gemcitabine hydrochloride and vinorelbine tartrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
123 sitesin 5 countries
Study dates
Jul 2004to Sep 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 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:
  • Not otherwise specified (NOS)
  • Mixed cellularity NOS
  • Lymphocytic depletion
  • NOS
  • Diffuse fibrosis
  • Reticular
  • Lymphocytic predominance
  • NOS
  • Diffuse
  • Nodular
  • Paragranuloma
  • Granuloma
  • Sarcoma
  • Nodular sclerosis
  • Cellular phase
  • NOS
  • Lymphocytic predominance
  • Mixed cellularity
  • Lymphocytic depletion NOTE: *Disease metastatic to bone marrow with granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable for hematological toxicity
  • Measurable disease by clinical or radiographic criteria
  • Relapsed or refractory to conventional therapy
  • Received at least 2 prior cytotoxic chemotherapy regimens
  • No stage IA or IIA nodal disease previously treated with any of the following:
  • Radiotherapy only
  • No more than 4 courses of prior chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 30 and under

Performance status

  • Karnofsky 50-100% (over 16 years of age)
  • Lansky 50-100% (16 and under) OR
  • ECOG 0-2

Life expectancy

  • At least 8 weeks

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 750/mm^3
  • Platelet count ≥ 75,000/mm^3 (transfusion independent, defined as ≥ 3 days since prior platelet transfusion)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN

Renal

  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
  • Creatinine based on age as follows:
  • No greater than 0.8 mg/dL (age 5 and under)
  • No greater than 1.0 mg/dL (age 6 to 10)
  • No greater than 1.2 mg/dL (age 11 to 15)
  • No greater than 1.5 mg/dL (over age 15)

Pulmonary

  • DLCO ≥ 50%
  • FEV_1 ≥ 50%
  • Vital capacity ≥ 50%
  • No evidence of dyspnea at rest
  • No exercise intolerance

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • Seizure disorder allowed provided patient is on anticonvulsants and disorder is well controlled
  • No evidence of active graft-versus-host disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 6 months since prior allogeneic stem cell transplantation (SCT)
  • At least 7 days since prior biologic agents
  • More than 3 months since prior autologous SCT
  • More than 1 week since prior growth factors
  • No concurrent immunomodulating agents

Chemotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week of each other)
  • Prior gemcitabine or vinorelbine administered alone is allowed
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids, including corticosteroids as an antiemetic or for control of graft-versus-host disease
  • Concurrent corticosteroids allowed only for the following indications:
  • Adrenal crisis in patients with suppressed pituitary/adrenal response
  • Noncardiogenic pulmonary edema
  • Allergic reactions to amphotericin or transfusions treated with low-dose hydrocortisone (less than 100 mg/m^2)

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • Concurrent immunosuppressive drugs allowed

Trial locations and contacts

123 sites in 5 countries.

123 sites in 5 countries

United States108 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062

  • Albany Medical Center Hospital

    Albany, New York, 12208-3419

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Texas Tech University Health Sciences Center School of Medicine - Amarillo

    Amarillo, Texas, 79106

  • C.S. Mott Children's Hospital at University of Michigan Medical Center

    Ann Arbor, Michigan, 48109-0238

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Floating Hospital for Children at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201-5493

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • T.C. Thompson Children's Hospital

    Chattanooga, Tennessee, 37403

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106-5000

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-5217

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78466

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404-1815

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Southern California Permanente Medical Group

    Downey, California, 90242-2814

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104-9958

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503-2560

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 95813

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030-2399

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40232

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics of Minneapolis

    Minneapolis, Minnesota, 55404

  • University of Minnesota Medical Center & Children's Hospital - Fairview

    Minneapolis, Minnesota, 55455

  • Overlook Hospital

    Morristown, New Jersey, 07962

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6310

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507-1971

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-9786

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113-1100

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229-3993

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99220-2555

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9620

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Stanford Comprehensive Cancer Center - Stanford

    Stanford, California, 94305

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Mary Bridge Children's Hospital and Health Center - Tacoma

    Tacoma, Washington, 98405

  • Madigan Army Medical Center - Tacoma

    Tacoma, Washington, 98431

  • St. Joseph's Cancer Institute at St. Joseph's Hospital

    Tampa, Florida, 33607

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19899

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada12 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • Montreal Children's Hospital at McGill University Health Center

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Centre Hospitalier Universitaire de Quebec

    Québec, G1V 4G2

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • CHUS-Hopital Fleurimont

    Sherbrooke, Alberta, J1H5N4

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia1 site

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

Other trials in Australia

Puerto Rico1 site

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

Switzerland1 site

  • Swiss Pediatric Oncology Group Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of pediatric patients with recurrent or refractory Hodgkin's lymphoma treated with gemcitabine and vinorelbine.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5 years.

Conditions
Lymphoma
Being tested
filgrastim, gemcitabine hydrochloride, vinorelbine tartrate
Keywords
recurrent/refractory childhood Hodgkin lymphoma, childhood lymphocyte predominant Hodgkin lymphoma, childhood lymphocyte depletion Hodgkin lymphoma, childhood nodular sclerosis Hodgkin lymphoma, childhood mixed cellularity Hodgkin lymphoma
Medical subject headings
Lymphoma, Recurrence, Hodgkin Disease

What participants receive

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

  • filgrastimBiological

    Also called Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen

    Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.

  • gemcitabine hydrochlorideDrug

    Also called Gemzar, NSC #613327

    Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8

  • vinorelbine tartrateDrug

    Also called Navelbine, NSC #608210

    Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8

Study groups in NCT00070304
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.
Receives: Biological: filgrastim; Drug: gemcitabine hydrochloride; Drug: vinorelbine tartrate

What is being measured

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

  1. Tumor Response Rate

    Adequate tumor response is defined as achieving CR, VGPR or PR at any evaluation.

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Toxicities

    Toxic death, hepatic, cardiac or renal toxicity, hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities

    Measured: Up to 4 weeks following the completion of therapy

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startJul 2004
  3. Primary completionSep 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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070304
Sponsor's protocol ID
AHOD0321
Other IDs
CDR0000331915, COG-AHOD0321
Status last verified
Jul 2013
First submitted
3 Oct 2003
Last updated
26 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Cole PD, McCarten KM, Drachtman RA, Alarcon Pd, Chen L, Trippett TM, Schwartz CL. Early [(1)(8)F]fluorodeoxyglucose positron emission tomography-based response evaluation after treatment with gemcitabine and vinorelbine for refractory Hodgkin disease: a children's oncology group report. Pediatr Hematol Oncol. 2010 Nov;27(8):650-7. doi: 10.3109/08880018.2010.504250.

    PubMed 20863157

  • Cole PD, Schwartz CL, Drachtman RA, de Alarcon PA, Chen L, Trippett TM. Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's disease: a children's oncology group report. J Clin Oncol. 2009 Mar 20;27(9):1456-61. doi: 10.1200/JCO.2008.20.3778. Epub 2009 Feb 17.

    PubMed 19224841

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, gemcitabine hydrochloride and vinorelbine tartrate in people with Lymphoma, run by Children's Oncology Group at 123 sites in 5 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 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Canada, Australia, Puerto Rico, Switzerland. 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?

Tumor Response Rate (time frame: Up to 1 year). 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 NCT00070304, which also lists 2 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 26 Jul 2013.

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