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

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Brief Title

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

Official Title

A Phase II Study of the Orally Administered Negative Enantiomer of Gossypol (AT-101) in Patients With Advanced Adrenocortical Carcinoma (ACC)

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 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.
    

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 acid.

      SECONDARY OBJECTIVES::

      I. To evaluate the safety of this drug in these patients. II. 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Overall Survival

Condition

Recurrent Adrenocortical Carcinoma

Intervention

R-(-)-gossypol acetic acid

Study Arms / Comparison Groups

 Treatment (R-(-)-gossypol acetic acid)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

February 2009

Completion Date

June 2012

Primary Completion Date

March 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Menefee, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00848016

Organization ID

NCI-2009-01160

Secondary IDs

MC0771

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Michael Menefee, Principal Investigator, Mayo Clinic


Verification Date

January 2014