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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Performance status:

- Not specified

Life expectancy:

- Not specified

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:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- See Cardiovascular

- 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

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nancy L. Bartlett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068042

NCT ID:

NCT00006029

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Washington University School of MedicineSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Weill Medical College of Cornell UniversityNew York, New York  10021
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722