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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

Inclusion Criteria

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
- 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
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 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

Exclusion Criteria

No concurrent combination antiretroviral therapy for HIV-positive patients

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (R-(-)-gossypol acetic acid)	R-(-)-gossypol acetic acid	Patients receive 20mg 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.

Primary Outcome Measures

Name	Time	Method
The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria	Up to 2 years	In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	From registration to progression or death, whichever occurs first, up to 2 years.	The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.
Overall Survival	From registration to date of last follow-up or death due to any cause, assessed up to 2 years	The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.

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

Recruitment & Eligibility

Study & Design

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