- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002921
S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery
Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II
RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing.
PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Duarte, California, United States, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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San Francisco, California, United States, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Springfield, Illinois, United States, 62526
- CCOP - Central Illinois
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Kansas
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Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Hospital - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Research & Treatment Center
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New York
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Syracuse, New York, United States, 13210
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-1329
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, United States, 78284
- University of Texas Health Science Center at San Antonio
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84132
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Suramin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response to suramin
Time Frame: From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles
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From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and grade of adverse events
Time Frame: From date of registration until progression or date of death from any cause, whichever came first, up to four cycles
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From date of registration until progression or date of death from any cause, whichever came first, up to four cycles
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Louis E. Schroder, MD, Barrett Cancer Center
Publications and helpful links
General Publications
- Shroder LE, Glass T, Eisenberger M, et al.: Phase II evaluation of suramin in advanced adrenal carcinoma: Southwest Oncology Group (SWOG) trial 9427. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2361, 153b, 2001.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Carcinoma
- Adrenocortical Carcinoma
- Anti-Infective Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Trypanocidal Agents
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
- Suramin
Other Study ID Numbers
- CDR0000065324
- U10CA032102 (U.S. NIH Grant/Contract)
- SWOG-9427 (Other Identifier: SWOG)
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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