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

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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
      courses.

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

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response to suramin

Secondary Outcome

 Number and grade of adverse events

Condition

Adrenocortical Carcinoma

Intervention

suramin

Study Arms / Comparison Groups

 Suramin
Description:  

Publications

* 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

Drug

Estimated Enrollment

13

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Louis E. Schroder, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002921

Organization ID

CDR0000065324

Secondary IDs

SWOG-9427

Responsible Party

Sponsor

Study Sponsor

Southwest Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

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


Verification Date

October 2012