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

NCT00848016 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-01160MC07718035CDR0000635024N01CM00070N01CM00038
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Adrenocortical Carcinoma; Stage III Adrenocortical Carcinoma; Stage IV Adrenocortical Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to 2 years

Secondary Outcomes (2)

• Overall Survival

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

• Progression-free Survival

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

Study Arms (1)

Treatment (R-(-)-gossypol acetic acid)

EXPERIMENTAL

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.

Drug: R-(-)-gossypol acetic acid

Interventions

R-(-)-gossypol acetic acid DRUG

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.

Also known as: AT-101

Treatment (R-(-)-gossypol acetic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No concurrent combination antiretroviral therapy for HIV-positive patients

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michael E. Menefee, M.D.
• Organization: Mayo Clinic Cancer Center

menefee.michael@mayo.edu

Study Officials

• Michael Menefee

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 7, 2014
• Results First Posted: February 21, 2014

Record last verified: 2014-01

Locations

US (2)