Study of Ipilimumab in the Immune System

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01715077
First received: October 12, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

Participants will be taking 10 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics.


Condition Intervention
Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
Drug: Ipilimumab at 10 mg/kg dose

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Correlative Study of Melanoma Tumor-Infiltrating Lymphocytes (TILs) and Response to Ipilimumab

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • TILs characteristics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Tumor-infiltrating lymphocytes (TILs)will be observed before and after 10mg/kg Ipilimumab is administered on patients with Stage III (unresectable) or Stage IV melanoma.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab
The recommended induction dose of ipilimumab is 10 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of four doses, as guided by laboratory tests and patient assessment.
Drug: Ipilimumab at 10 mg/kg dose

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Willing and able give written informed consent.
  2. Previously untreated and histologically confirmed Stage III (unresectable) or Stage IV melanoma. Adjuvant interferon is acceptable however.
  3. Subjects with asymptomatic brain metastases are eligible. (Systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose of steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose.)
  4. Must be at least 28 days since treatment with surgery or radiation, or immunotherapy (IFN-alpha), and recovered from any clinically significant toxicity experienced during treatment. Palliative radiation therapy outside of the brain or therapeutic radiation to the brain after the subject's condition is stabilized and steroid decreased to the lowest fixed dose possible does not require the 28- day waiting period.
  5. Easter Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  6. Life expectancy of more than 16 weeks.
  7. Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, pelvis, and bone scans. The images can be accepted if obtained 6 weeks before initiation of ipilimumab.
  8. Required values for initial laboratory tests: WBC > 2000/uL; ANC > 1000/uL; Platelets > 100 x 103/uL; Hemoglobin > 9 g/dL (> 80 g/L; may be transfused); Creatinine < 2.0 x ULN; AST/ALT < 2.5 x ULN for patients without liver metastasis, > 5 times for liver metastases; Bilirubin > 2.0 x ULN, (except patients with Gilber's Syndrome, who must have a total bilirubin less than 3.0 mg/dL); INR > 1.3
  9. No active or chronic infection HIV, Hepatitis B, or Hepatitis C.
  10. Men and women, greater or equal to 18 years of age.

Exclusion Criteria:

  1. Sex and Reproductive Status: a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the last dose of investigational product. b) WOCBP using a prohibited contraceptive method. c) Women who are pregnant or breastfeeding. D) Women with a positive pregnancy test on enrollment or before investigational product administration.
  2. Target Disease Exceptions: a) Subjects on any other systemic therapy for cancer, including any other experimental treatment. b) Prior treatment with an anti- CTLA-4 antibody if treatment failure was due to irAEs. If a subject was discontinued from the prior anti-CTLA-4 treatment due to an AE or SAE, regardless of the type of event, that discontinuation constitutes an exclusion criterion. If irAEs were serious enough to require a subject's withdrawal from prior treatment, the subject should be excluded from this study. c) Prior treatment with chemotherapy/biochemotherapy/immunotherapy for systemic disease for melanoma.
  3. Primary ocular and mucosal melanomas are not allowed.
  4. Medical History and Concurrent Diseases: a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. b) Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s). c) Presence of known hepatitis B or hepatitis C infection, regardless of control on antiviral therapy. d) Subjects with melanoma who have another active, concurrent, malignant disease with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
  5. Other Exclusion Criteria: a) Prisoners or subjects who are involuntarily incarcerated. b) Subjects who are compulsorily detained fro treatment of either a psychiatric or physical (e.g., infectious disease) illness. c) Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events. d) Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine.
  6. Any acute or chronic treatment with warfarin or antiplatelet agent (aspirin is allowed up tot a dose of 300 mg daily) including clopidogrel. Heparin, low molecular weight heparin, any heparinoid are allowed after appropriate cessation (usually 24 hours).
  7. Any known or suspected bleeding diathesis on the basis or personal or family history (including diagnoses of von Willebrands disease or other familial factor deficiency).
  8. The risk of the excision involves a significant risk of morbidity or mortality due to its size, location or vascularity (at the discretion of the principal investigators).
  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: NCT01715077

Contacts
Contact: Anthony Joshua, M.D 416-946-2520 Anthony.Joshua@uhn.ca

Locations
Canada, Ontario
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Anthony Joshua, M.D         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anthony Joshua, M.D UHN-Princess Margaet Hospital
  More Information

Publications:
Hamid, O., Chasalow, S. D., Tsuchihashi, Z., Alaparthy, S., Galbraith, S., and Berman, D. Association of baseline and on-study tumor biopsy markers with clinical activity in patients (pts) with advanced melanoma treated with ipilimumab. J Clin Oncol 27, 15s. 2009.

ClinicalTrials.gov Identifier: NCT01715077     History of Changes
Other Study ID Numbers: CA184-181
Study First Received: October 12, 2012
Last Updated: October 31, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
melanoma
stage IV
stage III
unresectable

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 24, 2014