A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma

October 3, 2022 updated by: Ludwig Institute for Cancer Research

A Phase II Study of Anti-CTLA-4 Antibody in Advanced Synovial Sarcoma Patients

The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is effective in people with advanced synovial sarcoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Approximately 750-900 people in the United States each year develop synovial sarcoma, a rare form of cancer of connective tissue. This tumor frequently metastasizes to other parts of the body such as the lungs. Chemotherapy can sometimes decrease the size of the recurrent tumors, but these results are usually only temporary, and the tumors grow again.

We are trying to exploit some of the proteins made by synovial sarcoma (cancer-germ cell or cancer-testis antigens) as targets for the immune system. Specifically, we are investigating if immune-based therapy with anti-CTLA-4 antibody once every 3 weeks for three treatments will activate the immune system enough to attack recurrent synovial sarcoma. In this study the tumor itself serves as the "vaccine" or source of protein, as we try to activate tumor-fighting T cells with the anti-CTLA-4.

Anti-CTLA-4 takes the brakes off the immune system to allow otherwise hidden immune responses to become more active. In so doing, there could be other side effects, such as immune system attacks against the normal organs of the body. We will follow both the anti-tumor immune responses with frequent blood tests and follow and treat side effects people develop on this study to determine if anti-CTLA-4 is worth pursuing in a larger number of patients with synovial sarcoma or other sarcomas.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically documented synovial sarcoma.
  • Patients with metastatic disease or locally recurrent disease who have failed or refused standard treatment. The disease must be measurable by RECIST.
  • Expected survival of at least 6 months.
  • Weight at least 35 kg.
  • ECOG performance scale 0-2.
  • At least 3 weeks since major surgery, and at least 3 weeks since completing radiation therapy or chemotherapy (6 weeks for patients receiving mitomycin C).
  • Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before treatment.
  • Adequate bone marrow, renal and hepatic function.
  • Able and willing to give valid written informed consent.

Exclusion Criteria:

  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, e.g. serious infections requiring antibiotics or bleeding disorders.
  • History of autoimmune disease.
  • Serious intercurrent illness, requiring hospitalization.
  • Patients with a second cancer diagnosis in the last five years, except for basal cell carcinoma, completely resected, or cervical carcinoma in situ (CIN), completely resected.
  • Known HIV positivity.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • Chronic use of immunosuppressive drugs such as systemic corticosteroids.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational agent within 3 weeks prior to enrollment.
  • Pregnancy or breast feeding.
  • Refusal or inability to use effective means of contraception (all men, and women with childbearing potential).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ipilimumab
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
Biological: ipilimumab
Other Names:
  • Yervoy
  • Anti-CTLA-4 monoclonal antibody
  • monoclonal antibody MDX-010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame: up to 10 weeks
Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With NY-ESO-1 Specific Immunity as Measured by Antibody Response to NY-ESO-1 or LAGE-1
Time Frame: up to 13 weeks
Blood samples were taken at baseline and weeks 4, 7, 10 and 13. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 or LAGE by enzyme-linked immunosorbent assay (ELISA). Positive results are reported as antibodies to NY-ESO-1- and/or LAGE-1-specific Total IgG (reciprocal titer).
up to 13 weeks
Number of Subjects Reporting Adverse Events (AEs)
Time Frame: up to 13 weeks
All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Institute for Cancer Research

Collaborators

Medarex

Investigators

  • Principal Investigator: Robert G Maki, MD PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2005

Primary Completion (Actual)

April 18, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUD2002-010
  • MSKCC 04-128 (Other Identifier: MSKCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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