S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery
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|ClinicalTrials.gov Identifier: NCT00002921|
Recruitment Status : Terminated (Permanently Closed Due to Lack of Accrual)
First Posted : July 30, 2004
Last Update Posted : October 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: suramin Drug: therapeutic hydrocortisone||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II|
|Study Start Date :||March 1997|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
Drug: therapeutic hydrocortisone
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002921
|Study Chair:||Louis E. Schroder, MD||Barrett Cancer Center|