S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery

Phase 2

Terminated

• Conditions: Adrenocortical Carcinoma
• Interventions: Drug: suramin; Drug: therapeutic hydrocortisone

• Registration Number: NCT00002921
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

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 Timeline

• Study Start: 1997-03
• Study First Submitted: 1999-11-01
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted QC: 2004-07-29
• Study First Posted: 2004-07-30
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suramin	therapeutic hydrocortisone	-
Suramin	suramin	-

Primary Outcome Measures

Name	Time	Method
Response to suramin	From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles

Secondary Outcome Measures

Name	Time	Method
Number and grade of adverse events	From date of registration until progression or date of death from any cause, whichever came first, up to four cycles

Trial Locations

Locations (65)

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

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