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

NCT00070304 | Completed Phase 2 DMC

• 3 other identifiers: AHOD0321CDR0000331915COG-AHOD0321
• Study Type: interventional
• Target: 33
• Locations: 5 countries
• Sites: 123

Brief 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. 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.

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)

• Tumor Response Rate

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

  Up to 1 year

Secondary Outcomes (1)

• Toxicities

  Up to 4 weeks following the completion of therapy

Study Arms (1)

Treatment

EXPERIMENTAL

Patients 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.

Biological: filgrastim; Drug: gemcitabine hydrochloride; Drug: vinorelbine tartrate

Interventions

filgrastim BIOLOGICAL

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.

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC # 614629

Treatment

gemcitabine hydrochloride DRUG

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

Also known as: Gemzar, NSC #613327

Treatment

vinorelbine tartrate DRUG

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

Also known as: Navelbine, NSC #608210

Treatment

Eligibility Criteria

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

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

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 (123)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, 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

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, 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

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

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Comprehensive Cancer Center - Stanford

Stanford, California, 94305, 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

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

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, 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

Nemours Children's Clinic - 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

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, 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

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, 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

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

Floating Hospital for Children at Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

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

Ann Arbor, Michigan, 48109-0238, 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 Hospital - 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

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

Children's Hospitals and Clinics of Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

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

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas Medical Center Cancer Center

Livingston, New Jersey, 07039, United States

Location

Overlook Hospital

Morristown, New Jersey, 07962, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Albany Medical Center Hospital

Albany, New York, 12208-3419, 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

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

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

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, 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

Tod Children's Hospital

Youngstown, Ohio, 44501, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

T.C. Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37916, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6310, United States

Location

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Amarillo, Texas, 79106, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78466, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

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

Dallas, Texas, 75390, 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, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229-3993, 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

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507-1971, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99220-2555, United States

Location

Mary Bridge Children's Hospital and Health Center - Tacoma

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

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

Charleston, West Virginia, 25302, 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

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 1Z2, Canada

Location

CHUS-Hopital Fleurimont

Sherbrooke, Alberta, J1H5N4, Canada

Location

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, 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

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, 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

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, G1V 4G2, Canada

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Swiss Pediatric Oncology Group Geneva

Geneva, 1205, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 20863157 RESULT

• 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.

  PMID: 19224841 RESULT

MeSH Terms

Conditions

Lymphoma; Recurrence; Hodgkin Disease

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Gemcitabine; 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)

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; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Peter Cole, MD

  Rutgers Cancer Institute of New Jersey

  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: October 3, 2003
• First Posted: October 7, 2003
• Study Start: July 1, 2004
• Primary Completion: September 1, 2007
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

US (108); PR (1); CH (1); CA (12); AU (1)