Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

Metastatic Disease Clinical Trial

Official title:

Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01861938
• Other study ID #: 0419-12-HMO
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 20, 2012
• Last updated: May 23, 2013
• Start date: June 2013

Study information

• Verified date: December 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israel Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Risk HLA-A2+ Melanoma
• Melanoma
• Metastatic Disease
• Neoplasm Metastasis

Intervention

Biological:
• Melanoma vaccine modified to express HLA A2/4-1BB ligand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emergence of anti-tumor T cell reactivity		To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start	No
Primary	Number of adverse effects		For 20 weeks from the start of treatment	Yes
Secondary	Overall and disease free survival		For at least five years	No