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Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II


Phase 2
18 Years
N/A
Not Enrolling
Both
Adrenocortical Carcinoma

Thank you

Trial Information

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II


OBJECTIVES: I. Assess the response of patients with adrenocortical carcinoma treated with
suramin. II. Evaluate the qualitative and quantitative toxic effects of this therapy.

OUTLINE: Patients are described according to stage, performance status, prior radiotherapy,
prior surgery, and prior mitotane therapy. Patients receive suramin IV for 5 days in the
first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks.
Hydrocortisone is taken PO twice daily. Following a 12 week rest, patients receive a second
course; those with stable or responding disease continue treatment for a maximum of four
courses.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued at a rate of 6-7 per year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adrenocortical carcinoma in Stage III or
IV and incurable by surgery Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: WBC
at least 4,000/mm3 Absolute granulocyte count at least 2,000/mm3 Platelet count at least
150,000/mm3 Prothrombin time and partial thromboplastin time no greater than upper limit
of normal (ULN) Hepatic: SGOT and alkaline phosphatase no greater than 2 times ULN Renal:
Creatinine clearance at least 50 mL/min Serum creatinine no greater than ULN Other: No
second malignancy within 5 years except adequately treated basal cell or squamous cell
carcinoma of the skin,in situ carcinoma of the cervix, or other cancer for which patient
has been disease free for 5 years Not pregnant or nursing Effective contraception required
of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy At least 4
weeks since prior biologic therapy (one regimen only) Chemotherapy: No concurrent
chemotherapy At least 4 weeks since prior mitotane No other prior chemotherapy allowed
Endocrine therapy: At least 6 weeks since prior hormonal therapy No concurrent hormonal
therapy Radiotherapy: At least 4 weeks since prior radiation therapy (to less than 25% of
bone marrow) No concurrent radiation therapy Surgery: Prior surgery allowed in relapsed
patients with no other prior treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to suramin

Outcome Time Frame:

From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles

Safety Issue:

No

Principal Investigator

Louis E. Schroder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barrett Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065324

NCT ID:

NCT00002921

Start Date:

March 1997

Completion Date:

January 2004

Related Keywords:

  • Adrenocortical Carcinoma
  • stage III adrenocortical carcinoma
  • stage IV adrenocortical carcinoma
  • Carcinoma
  • Adrenocortical Carcinoma
  • Adrenal Cortex Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Beckman Research Institute, City of HopeLos Angeles, California  91010
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Tulane University School of MedicineNew Orleans, Louisiana  70112
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Boston Medical CenterBoston, Massachusetts  02118
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932