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Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies


Phase 2
16 Years
N/A
Not Enrolling
Male
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

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Trial Information

Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies


OBJECTIVES:

- Determine the response rate (confirmed complete and partial responses) in men with
refractory testicular or extragonadal germ cell malignancies treated with arsenic
trioxide.

- Determine the overall and progression-free survival of patients treated with this drug.

- Determine the qualitative and quantitative toxic effects of this drug in these
patients.

- Assess the biomarker response rate in patients with elevated biomarkers treated with
this drug.

OUTLINE: This is a multicenter study.

Patients receive arsenic trioxide IV over 1-2 hours on days 1-5. Courses repeat every 28
days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Patients who achieve a confirmed complete or partial response receive up to 3 additional
courses past response.

Patients are followed every 2 months for 3 years or until disease progression.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed testicular or extragonadal germ cell cancer

- Refractory disease, defined by at least 1 of the following criteria:

- Disease progression during or within 4 weeks of cisplatin-containing regimen

- Progression is defined as the appearance of new or progression of known
locally advanced or metastatic disease or a rise in tumor markers
(beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP))
by at least 50% relative to the nadir

- When the only evidence of germ cell progression or recurrence before study
entry is the appearance of a new lesion in the absence of tumor marker
elevation, a biopsy is required to confirm the diagnosis

- Disease recurrence after at least 2 chemotherapy regimens, one of which includes
high-dose therapy (chemotherapy with stem cell support)

- Disease recurrence after at least 2 chemotherapy regimens and not eligible for
high-dose therapy

- At least 1 of the following:

- Unidimensionally measurable disease

- Soft tissue, irradiated within the past 2 months, is not considered
measurable

- Elevated beta-HCG (more than 20 mIU/mL)

- AFP greater than 2 times upper limit of normal

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Sex:

- Male

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- WBC at least 3,000/mm^3

Hepatic:

- Bilirubin less than 2.5 times upper limit of normal (ULN)

- SGOT less than 5 times ULN

- Alkaline phosphatase less than 5 times ULN

Renal:

- Creatinine no greater than 2.5 times ULN OR

- Creatinine clearance at least 40 mL/min

- Potassium normal

- Magnesium normal

- No renal dialysis

Cardiovascular:

- No prior torsades de pointes-type ventricular arrhythmia

- No prolonged QT interval (greater than 450 msec) on ECG in presence of normal
potassium and magnesium

Other:

- Fertile patients must use effective contraception

- No active serious infection not controlled by antibiotics

- No known hypersensitivity to arsenic

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or stage I or II disease in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

- More than 28 days since prior cytotoxic agents

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 28 days since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- More than 28 days since prior experimental agents

- No concurrent or planned drugs known to prolong the QT interval

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069328

NCT ID:

NCT00036842

Start Date:

April 2002

Completion Date:

June 2007

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • extragonadal germ cell tumor
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Western New York Urology AssociatesBuffalo, New York  14220
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075
Southwest Cancer and Research Center at University Medical CenterLubbock, Texas  79415-3364
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)Hines, Illinois  60141