Suspended

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

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What is being tested

suramin

+ therapeutic hydrocortisone

Drug
Who is being recruted

Adenocarcinoma+10

+ Adrenal Cortex Diseases

+ Adrenal Cortex Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1997
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: October 5, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002921
Principal SponsorSWOG Cancer Research Network
Last updated: October 5, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaAdrenal Cortex DiseasesAdrenal Cortex NeoplasmsAdrenal Gland DiseasesAdrenal Gland NeoplasmsCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialAdrenocortical Carcinoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 65 locations

MBCCOP - University of South Alabama

Mobile, United StatesOpen MBCCOP - University of South Alabama in Google Maps

CCOP - Greater Phoenix

Phoenix, United States

Arizona Cancer Center

Tucson, United States

University of Arkansas for Medical Sciences

Little Rock, United States
Suspended65 Study Centers