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Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

Phase 2
18 Years
Not Enrolling
Adrenocortical Carcinoma

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Trial Information

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to suramin

Outcome Time Frame:

From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles

Safety Issue:


Principal Investigator

Louis E. Schroder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barrett Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1997

Completion Date:

January 2004

Related Keywords:

  • Adrenocortical Carcinoma
  • stage III adrenocortical carcinoma
  • stage IV adrenocortical carcinoma
  • Carcinoma
  • Adrenocortical Carcinoma
  • Adrenal Cortex Neoplasms



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University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
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Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
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University of Mississippi Medical Center Jackson, Mississippi  39216-4505
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