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

Learn more about:
Related Clinical Trial
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma. The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma Natural History Study of Children and Adults With Adrenocortical Cancer (ACC) Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors Natural History Study of Infants With Adrenal Masses Found on Prenatal and/or Neonatal Imaging Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor International Pediatric Adrenocortical Tumor Registry Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer Structured Evaluation of adRENal Tumors Discovered Incidentally – Prospectively Investigating the Testing Yield Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy Sorafenib Plus Paclitaxel in Adreno-Cortical-Cancer Patients Efficacy of Adjuvant Mitotane Treatment (ADIUVO) Possible New Therapy for Advanced Cancer IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery Studying Genes in Samples From Younger Patients With Adrenocortical Tumor Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery Evaluation of Side Effects of Mitotane Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC) Surgery and Heated Chemotherapy for Adrenocortical Carcinoma Sunitinib in Refractory Adrenocortical Carcinoma Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical CarcInoma A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery Natural History and Tissue Acquisition Study of Adrenocortical Carcinoma Cabozantinib in Advanced Adrenocortical Carcinoma Trial With Taxotere and Cisplatin in Non-operable Adrenocortical Carcinoma German Adrenocortical Carcinoma Registry Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

Brief Title

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

Official Title

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

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

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

Study Phase

Phase 2

Study Type


Primary Outcome

Response to suramin

Secondary Outcome

 Number and grade of adverse events


Adrenocortical Carcinoma



Study Arms / Comparison Groups



* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

March 1997

Completion Date

January 2004

Primary Completion Date

January 2004

Eligibility 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




18 Years - N/A

Accepts Healthy Volunteers



Louis E. Schroder, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Southwest Oncology Group


 National Cancer Institute (NCI)

Study Sponsor

Louis E. Schroder, MD, Study Chair, Barrett Cancer Center

Verification Date

October 2012