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

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
  • Determine the complete and partial response rates of patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Phase I:

  • Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression. Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation.

Cohorts of 3-6 patients receive escalating doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with gemcitabine, vinorelbine, and doxorubicin HCl liposome at the recommended phase II dose.

Phase II:

  • Patients are assigned to 1 of 2 treatment groups.

    • Group 1: Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome as in phase I.
    • Group 2: Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome as in group 1.

Patients are followed every 6 months for 2 years and then annually for 6 years.

PROJECTED ACCRUAL: Approximately 3-100 patients (3-42 for phase I and 20-58 for phase II [29 per group]) will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Northeast Alabama Regional Medical Center
    • California
      • La Jolla, California, United States, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital Comprehensive Cancer Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • West Palm Beach, Florida, United States, 33401
        • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
      • Rockford, Illinois, United States, 61108
        • Saint Anthony Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East - Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Medical Center - Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center - University Campus
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center - St. Joseph
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, United States, 89106
        • Veterans Affairs Medical Center - Las Vegas
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • Veterans Affairs Medical Center - Asheville
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Concord, North Carolina, United States, 28025
        • NorthEast Oncology Associates
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Fayetteville, North Carolina, United States, 28302-2000
        • Cape Fear Valley Health System
      • Kinston, North Carolina, United States, 28503-1678
        • Lenoir Memorial Hospital Cancer Center
      • Pinehurst, North Carolina, United States, 28374
        • Firsthealth Moore Regional Hospital
      • Wilmington, North Carolina, United States, 28402-9025
        • New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Veterans Affairs Medical Center - Fargo
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Lifespan: The Miriam Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Veterans Affairs Medical Center - Dallas
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Green Mountain Oncology Group
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, United States, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Martha Jefferson Hospital
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Norfolk
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center
    • Wisconsin
      • Rhinelander, Wisconsin, United States, 54501
        • Ministry Medical Group - Northern Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vinorelbine + gemcitabine + doxorubicin - higher doses

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: vinorelbine tartrate
Drug: pegylated liposomal doxorubicin hydrochloride
Experimental: vinorelbine + gemcitabine + doxorubicin - lower doses

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: vinorelbine tartrate
Drug: pegylated liposomal doxorubicin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Nancy L. Bartlett, MD, Washington University Siteman Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-59804
  • CLB-59804
  • CDR0000068042 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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