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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00162500
Other study ID # 191203-HMO-CTIL
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 11, 2005
Last updated November 9, 2010

Study information

Verified date September 2005
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

Rationale:

ImMucin was shown to be able to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the majority of the target population.

Purpose:

The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).


Recruitment information / eligibility

Status Withdrawn
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients must have a histological or cytological diagnosis of metastatic disease expressing the MUC-1. Patients must have metastatic disease and have failed at least one regimen of standard based chemotherapy for metastatic disease such as:

- Renal Cell Carcinoma (RCC),

- Transitional Cell Carcinoma (TCC),

- Prostate,

- Breast,

- Ovary,

- Non-small cell lung,

- Colon,

- Multiple myeloma and

- Pancreatic.

- Patients must be >18 years of age, consenting to participation in the study.

- Patients must have at least one site of measurable tumor or measurable tumor marker.

Exclusion Criteria:

- Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine.

- Subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. However, patients who had standard pelvic field radiation such as adjuvant therapy for rectal cancer are not excluded.

- Pregnant and breast feeding women will be excluded. Premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.

- Patients with brain metastases.

- Patients with active infection.

- Patients with HIV hepatitis B surface antigen (HBS Ag) and hepatitis C virus (HCV) positive patients.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Peptide Vaccine (MUC-1)


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (2)

Lead Sponsor Collaborator
Hadassah Medical Organization Vaxil Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the safety and tolerability of vaccination comprising the ImMucin vaccine
Primary combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients
Primary with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas
Secondary Determine objective anti-tumor response in patients treated with this regimen;
Secondary Determine immune response in patients treated with this regimen
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