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

NCT00006029 | Completed Phase 1 DMC

• 3 other identifiers: CALGB-59804CLB-59804CDR0000068042
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 76

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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Up to 4 years

Secondary Outcomes (1)

• Overall survival

  Up to 4 years

Study Arms (2)

vinorelbine + gemcitabine + doxorubicin - higher doses

ACTIVE COMPARATOR

Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome. Patients are followed every 6 months for 2 years and then annually for 6 years.

Drug: gemcitabine hydrochloride; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: vinorelbine tartrate

vinorelbine + gemcitabine + doxorubicin - lower doses

EXPERIMENTAL

Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome. Patients are followed every 6 months for 2 years and then annually for 6 years.

Drug: gemcitabine hydrochloride; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: vinorelbine tartrate

Interventions

gemcitabine hydrochloride DRUG

vinorelbine + gemcitabine + doxorubicin - higher doses; vinorelbine + gemcitabine + doxorubicin - lower doses

pegylated liposomal doxorubicin hydrochloride DRUG

vinorelbine + gemcitabine + doxorubicin - higher doses; vinorelbine + gemcitabine + doxorubicin - lower doses

vinorelbine tartrate DRUG

vinorelbine + gemcitabine + doxorubicin - higher doses; vinorelbine + gemcitabine + doxorubicin - lower doses

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy * Core biopsy is acceptable if adequate tissue is obtained for primary diagnosis and immunophenotyping * Bone marrow biopsy is not acceptable as sole means of diagnosis * Measurable disease * Tumor mass greater than 1 cm PATIENT CHARACTERISTICS: Age: * Any age Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL unless history of Gilbert's disease * AST no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * LVEF at least 45% by MUGA (for patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m\^2) Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior gemcitabine, vinorelbine, or doxorubicin HCl liposome * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormones except for nondisease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure * No concurrent dexamethasone or other steroidal antiemetics

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (76)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36207, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center

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

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Regional Hospital Comprehensive Cancer Center

Hollywood, Florida, 33021, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center

West Palm Beach, Florida, 33401, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Baptist Hospital East - Louisville

Louisville, Kentucky, 40207, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Veterans Affairs Medical Center - Asheville

Asheville, North Carolina, 28805, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

NorthEast Oncology Associates

Concord, North Carolina, 28025, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28302-2000, United States

Location

Lenoir Memorial Hospital Cancer Center

Kinston, North Carolina, 28503-1678, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402-9025, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Veterans Affairs Medical Center - Dallas

Dallas, Texas, 75216, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22901, United States

Location

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, 23502, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

Ministry Medical Group - Northern Region

Rhinelander, Wisconsin, 54501, United States

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (3)

• Lai R, Bartlett NL, Mackey JR, Jung SH, Johnson JL, Cook JR, Jones D, Cass CE, Young JD, Said J, Cheson B, Hsi ED. High expression of nucleoside transporter protein hENT1 in Reed-Sternberg cells is associated with treatment failure in relapsed/refractory Hodgkin lymphoma patients treated with gemcitabine, vinorelbine and liposomal doxorubicin - a CALGB 59804 correlative study. Leuk Lymphoma. 2008 Jun;49(6):1202-5. doi: 10.1080/10428190802094237. No abstract available.

  PMID: 18452103 RESULT

• Bartlett NL, Niedzwiecki D, Johnson JL, Friedberg JW, Johnson KB, van Besien K, Zelenetz AD, Cheson BD, Canellos GP; Cancer Leukemia Group B. Gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD), a salvage regimen in relapsed Hodgkin's lymphoma: CALGB 59804. Ann Oncol. 2007 Jun;18(6):1071-9. doi: 10.1093/annonc/mdm090. Epub 2007 Apr 10.

  PMID: 17426059 RESULT

• Bartlett N, Niedzwiecki D, Johnson J, et al.: A phase I/II study of gemcitabine, vinorelbine, and liposomal doxorubicin for relapsed Hodgkin's disease: preliminary results of CALGB 59804. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2275, 566, 2003.

  RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Recurrence

Interventions

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)

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

• Nancy L. Bartlett, MD

  Washington University Siteman Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

PR (1); US (75)