Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
Recruitment status was Recruiting
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Purpose
The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Malignant Melanoma |
Biological: DC vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma |
- to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
- to investigate the clinical tumor response and the duration [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
- to evaluate the duration of tumor and immunoresponse [ Time Frame: 3, 6, 9 months ] [ Designated as safety issue: No ]
- to evaluate immune response [ Time Frame: at 8 and 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 14 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DC vaccination and Cyclophosphamide |
Biological: DC vaccine
DC vaccination, one vaccine biweekly
Other Names:
|
Detailed Description:
Phase I trial. Single center study; patients will be referred to the study center from other institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine adjuvant.
Defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and transfected with mRNA encoding for hTERT, survivin and p53 if the tumour express p53. Frozen preparations of dendritic cells will be prepared using automated cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological verified metastatic breast cancer or malignant melanoma, in progression
- ≥ 18 years
- the patient must be habil
- Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
- Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
- creatinin must be normal
- Liverparametre <2.5 x normal. Bilirubin <30
- Expected survival > 3 months
- Informed consent
11. At least one measurable lesion according to RECIST criteria.
Exclusion Criteria:
- Indication for chemotherapy
- Other malignancies
- Brain metastases
- severe medical condition
- Acute/chronic infection with ex. HIV, hepatitis, tuberculose
- Severe allergy
- Autoimmune disease
- Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
- Uncontrolled hypercalcemia.
Contacts and Locations| Contact: Inge Marie Svane, prof.MD | +4544884488 | imsv@heh.regionh.dk |
| Contact: Lotte Engell-Nørregård, MD | +4544884488 | loteng02@heh.regionh.dk |
| Denmark | |
| Department of Oncology, Herlev University Hospital | Recruiting |
| Herlev, Denmark, Dk 2730 | |
| Contact: Inge Marie Svane, Prof.MD +4544884488 imsv@heh.regionh.dk | |
| Contact: Lotte Engell-Nørregård, MD +4544884488 loteng02@heh.regionh.dk | |
| Study Director: | Inge Marie Svane, prof.MD | Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev |
More Information
No publications provided
| Responsible Party: | Inge Marie Svane prof. MD, Department of oncology, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT00978913 History of Changes |
| Other Study ID Numbers: | AA 0914 |
| Study First Received: | September 16, 2009 |
| Last Updated: | October 3, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Herlev Hospital:
|
dendritic cell cancervaccine breast cancer malignant melanoma Cyclophosphamide |
Additional relevant MeSH terms:
|
Breast Neoplasms Melanoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013