Status:
COMPLETED
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adrenocortical Carcinoma
Stage III Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic a...
Eligibility Criteria
Inclusion
- 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
- No concurrent combination antiretroviral therapy for HIV-positive patients
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00848016
Start Date
February 1 2009
End Date
June 1 2012
Last Update
May 7 2014
Active Locations (2)
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1
University of Southern California
Los Angeles, California, United States, 90033-0804
2
Mayo Clinic
Rochester, Minnesota, United States, 55905