Clinical Study of WT2725 in Patients With Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Sunovion
Sponsor:
Collaborator:
Dainippon Sumitomo Pharma
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01621542
First received: June 6, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity of WT2725. WT2725 will be administered to patients with advanced solid malignancies known to overexpress WT1


Condition Intervention Phase
Cancer
Biological: WT2725
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Initial Phase 1 Study of WT2725 in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Occurrence of dose-limiting toxicities and adverse events [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
    Occurrence of dose-limiting toxicities and adverse events whilst on study treatment (Day 1) and ending 30 days after the last study treatment administration; an expected average of 4 months

  • To determine the maximum tolerated dose (MTD) of WT2725 based on the evaluation of dose-limiting toxicity (DLT) [ Time Frame: Day 1 - Day 29 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe antitumor responses to WT2725 based on the immune-related response criteria (irRC) [ Time Frame: Day 1 - within 28 days after last dose ] [ Designated as safety issue: No ]
  • To evaluate the immune response to WT2725 [ Time Frame: Day 1 - within 28 days after last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WT2725
WT2725; injection
Biological: WT2725
WT2725 injection Study drug will be administered every 1-4 weeks

Detailed Description:

Treatment with other WT1 vaccines in clinical trials has shown evidence of immunogenicity and clinical response in various malignancies.

This study will assist with determining which doses level(s) and route(s) of administration to use in future clinical studies. In addition, this study will evaluate both clinical and immunological response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0, 1, or 2
  • Patient must have one of the following histologically or cytologically documented measurable (may be measureable by tumor markers only, such as quantitative RT-PCR for WT1 transcript for AML, or CA-125 for ovarian carcinoma) advanced stage malignancies: non-small cell lung, ovarian, glioblastoma, and AML (not including acute promyelocytic leukemia), known to overexpress the WT1 protein.
  • Patient must qualify with a study specific HLA typing assay.
  • Haematological parameters:

    • Absolute neutrophil count (ANC) ≥ 1,000/μl
    • Platelet count ≥ 10.0x10^4/μl (≥ 5.0 x 10^4/μl after stem cell transplant)
    • Hemoglobin ≥ 9.0 g/dL
    • Absolute lymphocyte count (ALC) ≥ 1,000/μl (≥ 500/μl after stem cell transplant) Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria.
  • Biochemical Parameters:

    • serum creatinine of ≤ 1.5x upper limit of normal (ULN) for the reference lab.
    • total bilirubin of ≤ 2.0 mg/dl (≤ 3.0 mg/dl for patients with known Gilbert's syndrome)
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the ULN for the reference lab
  • Patient must have access to archival tumor tissue sample or agree to undergo biopsy after study eligibility has been confirmed to obtain fresh sample for evaluation of WT1 expression. In place of archival tumor tissue samples, subjects with AML should have available a bone marrow aspirate and/or, bone marrow biopsy with RT-PCR for WT1 transcript performed before the first dose of study drug. Note: The archived tumor tissue sample does not need to be delivered to the clinical site prior to enrollment of the patient, however its availability should be confirmed through provision of the accession number or other identification number

Exclusion Criteria:

  • Patient with an extensively disseminated primary glioblastoma.
  • Patient with symptomatic brain metastases, ie, not neurologically stable or requiring treatment with corticosteroids, or central nervous system (CNS) leukemia.
  • Patient with an infection requiring treatment with systemic antibiotics or antiviral medication or has completed treatment for such an infection within 4 days prior to planned initial dose of WT2725.
  • Patient requiring systemic, pharmacologic doses of corticosteroids (equivalent to > 60 mg hydrocortisone/day or 2 mg dexamethasone/day). Replacement doses (equivalent to ≤ 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed.
  • Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus (HIV)-1, or HIV-2 antibody, or has a history of a positive result.
  • Patient has received any of the following treatments within the specified timeframe prior to dosing:

    • endocrine therapy, immunotherapy, transfusion, hematopoietic factors within 14 days prior to planned first dose of study drug (Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria, eg. transfusions and hematopoietic growth factors.)
    • chemotherapy including molecular-targeting therapy within 21 days (for molecular-targeted agents that are not associated with myelosuppression or immunosuppression, the minimum interval is 5 half-lives if that is less than 21 days)
    • surgery, radiation, or immunosuppressants within 28 days
    • investigational drug within 28 days
    • mitomycin-C or nitrosoureas within 42 days
  • Patient with an unresolved ≥ Grade 2 AE from a previous antineoplastic treatment, excluding alopecia.
  • Pregnant or lactating women
  • Patient with an autoimmune condition
  • Patients with serious unstable medical illness
  • Patient with pleural effusion, ascites, or pericardial fluid requiring drainage.
  • Patient is a staff member of the sponsor or clinical site and is involved in the conduct of the study or the relative of such a staff member
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621542

Contacts
Contact: Study Manager 866-503-6351

Locations
United States, Arizona
The University of Arizona Cancer Center - North Campus Recruiting
Tucson, Arizona, United States, 85719
Contact: Jeanette S. Cardenas    520-694-9082    JSerrano@azcc.arizona.edu   
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Study Coordinator    858-822-7524      
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-2084      
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Study Coordinator    717-531-3828      
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Dr. David Hong    713-563-5844      
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-794-5783      
Sponsors and Collaborators
Sunovion
Dainippon Sumitomo Pharma
Investigators
Study Director: Head of Biotherapeutics, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01621542     History of Changes
Other Study ID Numbers: D8350004
Study First Received: June 6, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Cancer
Vaccine
Oncology
Malignancies
Wilms' Tumor
WT1
Non-small cell lung cancer [NSCLC]
Ovarian
Glioblastoma [GBM]
Acute myeloid leukemia [AML]

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014