Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma

NCT00006760 | Completed Phase 2 DMC

• 5 other identifiers: AHOD00P1CCG-A5981CDR0000068325NCI-2012-02366U10CA098543
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 114

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in 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: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.

Conditions

Lymphoma

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response includes complete response (CR) or partial response (PR).

  After 2 cycles

Secondary Outcomes (4)

• Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg

  After 2 cycles

• Biologic markers

  At enrollment and during/after therapy

• Cardiac, hepatic, renal, hematologic toxicity

  Within 1 month of completion of therapy

• Toxic death

  Within 1 month of Completion of therapy

Study Arms (1)

Treatment (ifosfamide, vinorelbine, filgrastim)

EXPERIMENTAL

Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.

Biological: filgrastim; Drug: ifosfamide; Drug: vinorelbine tartrate

Interventions

filgrastim BIOLOGICAL

subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.

Treatment (ifosfamide, vinorelbine, filgrastim)

ifosfamide DRUG

V over 24 hours on days 1-4

Treatment (ifosfamide, vinorelbine, filgrastim)

vinorelbine tartrate DRUG

IV over 6-10 minutes on days 1 and 5.

Treatment (ifosfamide, vinorelbine, filgrastim)

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed refractory or relapsed Hodgkin's lymphoma * Mixed cellularity, not otherwise specified (NOS) * Lymphocytic depletion, NOS * Lymphocytic depletion, diffuse fibrosis * Lymphocytic depletion, reticular * Lymphocytic predominance, NOS * Lymphocytic predominance, diffuse * Lymphocytic predominance, nodular * Hodgkin's paragranuloma NOS * Hodgkin's granuloma * Hodgkin's sarcoma * Nodular sclerosis, NOS * Nodular sclerosis, cellular phase * Nodular sclerosis, lymphocytic predominance * Nodular sclerosis, mixed cellularity * Nodular sclerosis, lymphocytic depletion * Other (type not specified) * In first relapse * Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed * Not enrolled on POG-9426 unless there is an extranodal site of recurrence PATIENT CHARACTERISTICS: Age: * Under 30 at diagnosis Performance status: * Lansky 60-100% (for patients 16 years and under) * Karnofsky 60-100% (for patients over 16 years) Life expectancy: * At least 2 months Hematopoietic: * See Disease Characteristics * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion independent) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT or SGPT less than 2.5 times normal Renal: * Creatinine no greater than 1.5 times normal * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular: * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by gated radionuclide Other: * No other concurrent serious illness * No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunomodulating agents Chemotherapy: * At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered * No other concurrent anticancer chemotherapy Endocrine therapy: * No concurrent steroids * No concurrent corticosteroids (e.g., dexamethasone) Radiotherapy: * Recovered from prior radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (114)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016-7710, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242-2814, United States

Location

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Kaiser Permanente Medical Center - Oakland

Sacramento, California, 95825, United States

Location

Children's Hospital and Health Center - San Diego

San Diego, California, 92123-4282, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Children's Hospital Cancer Center

Denver, Colorado, 80218-1088, United States

Location

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

Farmington, Connecticut, 06360-2875, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

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

Location

Lee Cancer Care of Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

M.D. Anderson Cancer Center - Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

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

Tampa, Florida, 33607, United States

Location

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

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

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 95813, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712-6297, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9620, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40232, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

CancerCare of Maine at Eastern Maine Medial Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074-9308, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503-2560, United States

Location

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

Grosse Pointe Woods, Michigan, 48236, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-5341, United States

Location

Children's Hospital of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2511, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201-5493, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

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

Rochester, New York, 14642, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794-8174, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-5217, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Institute of Oncology at Vilnius University

Portland, Oregon, 97227, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

T.C. Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104-9958, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

INOVA Fairfax Hospital

Fairfax, Virginia, 22031, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507-1971, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

Carilion Cancer Center of Western Virginia

Roanoke, Virginia, 24029, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Ste-Foy, Quebec, G1V 4G2, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Lymphoma; Recurrence; Hodgkin Disease

Interventions

Filgrastim; Ifosfamide; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Tanya Trippett, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

• Pedro A. de Alarcon, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: July 1, 2005
• Study Completion: March 1, 2012
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

US (101); CA (10); AU (3)