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Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01861938
Recruitment Status : Unknown
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2013
Last Update Posted : May 24, 2013
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE May 24, 2013
Last Update Posted Date May 24, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Number of adverse effects [ Time Frame: For 20 weeks from the start of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Overall and disease free survival [ Time Frame: For at least five years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2013)
Emergence of anti-tumor T cell reactivity [ Time Frame: To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start ]
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
Official Title  ICMJE Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
Brief Summary

This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.

Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.

In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • High Risk HLA-A2+ Melanoma
  • Metastatic Disease
Intervention  ICMJE Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand
Study Arms  ICMJE Experimental: Melanoma vaccine
Intervention: Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
  2. Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
  3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
  4. Metastatic melanoma AJCC stage IV, completely resected.
  5. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
  6. Melanoma can be of either mutant or wild-type B-RAF.
  7. Karnofsky performance status over 80 (Normal activity with effort).
  8. No active cardio-respiratory disease.
  9. Hematocrit over 25% and WBC over 3000.
  10. Informed consent of the patient.

Exclusion Criteria:

  1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
  2. Active brain metastases requiring cortico-steroids.
  3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
  4. Active serious infection.
  5. Allergy to penicillin.
  6. Patient's wish to withdraw from the study at any stage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01861938
Other Study ID Numbers  ICMJE 0419-12-HMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP