Clinical trial NCT00162500: A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Official title: A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Myeloma
Tumors
Keywords: Metastatic solid tumors
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Vaxil Therapeutics Ltd.
First posted: 2005-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the safety and tolerability of vaccination comprising the ImMucin vaccine
measure: combined with Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in patients
measure: with multiple myeloma and other MUC-1 antigen-expressing metastatic carcinomas
Secondary outcomes:
measure: Determine objective anti-tumor response in patients treated with this regimen;
measure: Determine immune response in patients treated with this regimen
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References: