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Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NCT00003666)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
  • Drug: 6-hydroxymethylacylfulvene
    11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
    • irofulven
Ages eligible for Study
18 Years to 120 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.

OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.

PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.

48 locations

United States (48)
  • Veterans Affairs Medical Center - Birmingham
    Birmingham, Alabama, United States, 35233
  • University of California San Diego Cancer Center
    La Jolla, California, United States, 92093-0658
  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California, United States, 94115-0128
  • Veterans Affairs Medical Center - San Francisco
    San Francisco, California, United States, 94121
  • CCOP - Christiana Care Health Services
    Wilmington, Delaware, United States, 19899
  • Vincent T. Lombardi Cancer Research Center, Georgetown University
    Washington, District of Columbia, United States, 20007
  • Walter Reed Army Medical Center
    Washington, District of Columbia, United States, 20307-5000
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida, United States, 33140
  • University of Illinois at Chicago Health Sciences Center
    Chicago, Illinois, United States, 60612
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois, United States, 60612
  • University of Chicago Cancer Research Center
    Chicago, Illinois, United States, 60637
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa, United States, 52242
  • Veterans Affairs Medical Center - Togus
    Togus, Maine, United States, 04330
  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    Baltimore, Maryland, United States, 21201
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts, United States, 02114
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States, 02115
  • University of Massachusetts Memorial Medical Center
    Worcester, Massachusetts, United States, 01655
  • Veterans Affairs Medical Center - Minneapolis
    Minneapolis, Minnesota, United States, 55417
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
    Columbia, Missouri, United States, 65201
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri, United States, 65203
  • Barnes-Jewish Hospital
    Saint Louis, Missouri, United States, 63110
  • Veterans Affairs Medical Center - Omaha
    Omaha, Nebraska, United States, 68105
  • University of Nebraska Medical Center
    Omaha, Nebraska, United States, 68198-3330
  • CCOP - Southern Nevada Cancer Research Foundation
    Las Vegas, Nevada, United States, 89106
  • Norris Cotton Cancer Center
    Lebanon, New Hampshire, United States, 03756
  • Veterans Affairs Medical Center - Buffalo
    Buffalo, New York, United States, 14215
  • Roswell Park Cancer Institute
    Buffalo, New York, United States, 14263-0001
  • CCOP - North Shore University Hospital
    Manhasset, New York, United States, 11030
  • North Shore University Hospital
    Manhasset, New York, United States, 11030
  • Memorial Sloan-Kettering Cancer Center
    New York, New York, United States, 10021
  • New York Presbyterian Hospital - Cornell Campus
    New York, New York, United States, 10021
  • Mount Sinai Medical Center, NY
    New York, New York, United States, 10029
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    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, 13210
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina, United States, 27599-7295
  • Veterans Affairs Medical Center - Durham
    Durham, North Carolina, United States, 27705
  • Duke Comprehensive Cancer Center
    Durham, North Carolina, United States, 27710
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina, United States, 27104-4241
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina, United States, 27157-1082
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio, United States, 43210
  • Rhode Island Hospital
    Providence, Rhode Island, United States, 02903
  • Medical University of South Carolina
    Charleston, South Carolina, United States, 29425-0721
  • Veterans Affairs Medical Center - Memphis
    Memphis, Tennessee, United States, 38104
  • University of Tennessee, Memphis Cancer Center
    Memphis, Tennessee, United States, 38163
  • Veterans Affairs Medical Center - White River Junction
    White River Junction, Vermont, United States, 05009
  • Veterans Affairs Medical Center - Richmond
    Richmond, Virginia, United States, 23249
  • MBCCOP - Massey Cancer Center
    Richmond, Virginia, United States, 23298-0037
Status:
completed
Type:
Interventional
Phase:
Start:
31 October, 1998
Updated:
18 July, 2016
Participants:
36
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