A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

NCT00162500 | Withdrawn Phase 2

• 1 other identifier: 191203-HMO-CTIL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Myeloma; Tumors

Keywords

Metastatic solid tumors

Outcome Measures

Primary Outcomes (3)

• Determine the safety and tolerability of vaccination comprising the ImMucin vaccine

• combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients

• with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas

Secondary Outcomes (2)

• Determine objective anti-tumor response in patients treated with this regimen;

• Determine immune response in patients treated with this regimen

Interventions

Peptide Vaccine (MUC-1) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Vaxil Therapeutics Ltd.: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Interventions

Protein Subunit Vaccines

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Shimon Slavin, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 13, 2005
• Last Updated: November 10, 2010

Record last verified: 2005-09

Locations

IL (1)