Clinical Trials

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

Location:

Scottsdale and Phoenix,  AZ,  Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

Primary

- To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid.

Secondary

- To evaluate the safety of this drug in these patients.

- To determine the progression-free and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

- Life expectancy ≥ 12 weeks

- WBC ≥ 3,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin < 1.5 mg/dL

- AST and 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

- Psychiatric illness or social situation that would limit compliance with study requirements

- No condition or disease that significantly affects gastrointestinal (GI) function or impairs the ability to swallow and retain oral medications including, but not limited to, any of the following:

- GI tract disease or a requirement for IV alimentation

- Prior resection of the stomach or small bowel or surgical procedures affecting absorption

- Active peptic ulcer disease

- Malabsorption syndrome

- Ulcerative colitis

- Inflammatory bowel disease

- Partial or complete small bowel obstruction

- No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ cervical cancer

- No symptomatic hypercalcemia > grade 2

- No history of allergic reactions attributed to compounds of similar chemical or biological composition to R-(-)-gossypol acetic acid

PRIOR CONCURRENT THERAPY:

- Fully recovered from prior surgical procedures and recovered to ≤ grade 1 from adverse events due to previous treatments

- No prior racemic gossypol or R-(-)-gossypol acetic acid

- More than 4 weeks since prior chemotherapy, biologic therapy, major surgery, or radiotherapy (≥ 6 weeks for carmustine or mitomycin C)

- Prior and concurrent mitotane and ketoconazole allowed for patients with hormonal excess

- More than 4 weeks since prior and no concurrent treatment with another investigational agent

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent prophylactic use of hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-11) during the first course of study treatment

- Not requiring routine use of platelet transfusions to maintain ANC or platelet count above required thresholds

Last updated: 03/26/2012

NCT ID:

NCT00848016