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Recurrent Adrenocortical CarcinomaPhase 2NCT00848016

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

A Phase 2 study testing R-(-)-gossypol acetic acid in people with Recurrent Adrenocortical Carcinoma and Stage III Adrenocortical Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
R-(-)-gossypol acetic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
Feb 2009to Jun 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 44Show fewer
  • 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

Who cannot join

  • No concurrent combination antiretroviral therapy for HIV-positive patients

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Southern California

    Los Angeles, California, 90033-0804

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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::

  1. 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.

Being tested
R-(-)-gossypol acetic acid
Medical subject headings
Adrenocortical Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-(-)-gossypol acetic acidDrug

    Also called AT-101

    Participants take 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.

Study groups in NCT00848016
Study groupRoleWhat they receive
Treatment (R-(-)-gossypol acetic acid)ExperimentalPatients 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.
Receives: Drug: R-(-)-gossypol acetic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Overall Survival

    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.

    Measured: From registration to date of last follow-up or death due to any cause, assessed up to 2 years

  2. Progression-free Survival

    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.

    Measured: From registration to progression or death, whichever occurs first, up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00848016
Sponsor's protocol ID
NCI-2009-01160
Other IDs
MC0771, 8035, CDR0000635024, N01CM00070, N01CM00038
Status last verified
Jan 2014
First submitted
19 Feb 2009
Last updated
7 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R-(-)-gossypol acetic acid in people with Recurrent Adrenocortical Carcinoma and Stage III Adrenocortical Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00848016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

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