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

NCT00140855 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: LUD2002-010MSKCC 04-128
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Synovial Sarcoma

Keywords

synovial sarcoma; immunotherapy; cancer-testis antigen; cancer-germ cell antigen; soft tissue sarcoma; SYT-SSX chromosomal translocation

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).

  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 Outcomes (2)

• Number of Subjects With NY-ESO-1 Specific Immunity as Measured by Antibody Response to NY-ESO-1 or LAGE-1

  up to 13 weeks

• Number of Subjects Reporting Adverse Events (AEs)

  up to 13 weeks

Study Arms (1)

ipilimumab

EXPERIMENTAL

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

Interventions

ipilimumab BIOLOGICAL

Also known as: Anti-CTLA-4 monoclonal antibody, monoclonal antibody MDX-010, Yervoy

ipilimumab

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• Medarex: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

• Maki RG, Jungbluth AA, Gnjatic S, Schwartz GK, D'Adamo DR, Keohan ML, Wagner MJ, Scheu K, Chiu R, Ritter E, Kachel J, Lowy I, Old LJ, Ritter G. A Pilot Study of Anti-CTLA4 Antibody Ipilimumab in Patients with Synovial Sarcoma. Sarcoma. 2013;2013:168145. doi: 10.1155/2013/168145. Epub 2013 Feb 27.

  PMID: 23554566 RESULT

Related Links

• Link to MSKCC Sarcoma Clinical trial web site highlighting anti-CTLA4 protocol

MeSH Terms

Conditions

Sarcoma, Synovial; Sarcoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This study was terminated early due to slow recruitment.

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Robert G Maki, MD PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: June 8, 2005
• Primary Completion: April 18, 2007
• Study Completion: July 1, 2007
• Last Updated: October 12, 2022
• Results First Posted: July 14, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)