Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Recurrent Adrenocortical Carcinoma, Stage III Adrenocortical Carcinoma, Stage IV Adrenocortical Carcinoma

In brief

This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID

NCT00848016

Run by

National Cancer Institute (NCI)

People needed

29

Starts

2009-02-01

Expected to finish

2012-06-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adrenocortical carcinoma
• Recurrent, metastatic, or primary unresectable disease
• Measurable disease, defined as ≥ 1 lesion accurately measured in ≥ 1 dimension as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
• No adrenocortical tumors that, in the Principal Investigator's opinion, are potentially resectable by surgical excision alone
• No symptomatic or progressive brain metastases
• Patients with treated brain metastases ≥ 6 months prior to study who are clinically and radiographically stable or improved and are off steroids are eligible
• Must undergo an MRI of the brain or CT scan of the head with contrast ≤ 4 weeks prior to study
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy ≥ 12 weeks
• White blood cell count (WBC) ≥ 3,000/mm3
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Total bilirubin < 1.5 mg/dL
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
• Serum creatinine ≤ 1.7 mg/dL or creatinine clearance ≥ 40 mL/min
• Able to take oral medications on a regular basis
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during, and for ≥ 1 month after completion of study treatment
• No HIV positivity
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia

You may not qualify if…

• No concurrent combination antiretroviral therapy for HIV-positive patients

Where it is running

• University of Southern California — Los Angeles, California, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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