Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00978913
First received: September 16, 2009
Last updated: October 3, 2011
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • dendritic cell vaccine
  • Cyclophosphamide, Sendoxan®, Baxter

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
Criteria

Inclusion Criteria:

  1. Histological verified metastatic breast cancer or malignant melanoma, in progression
  2. ≥ 18 years
  3. the patient must be habil
  4. Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
  5. Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
  6. creatinin must be normal
  7. Liverparametre <2.5 x normal. Bilirubin <30
  8. Expected survival > 3 months
  9. Informed consent

11. At least one measurable lesion according to RECIST criteria.

Exclusion Criteria:

  1. Indication for chemotherapy
  2. Other malignancies
  3. Brain metastases
  4. severe medical condition
  5. Acute/chronic infection with ex. HIV, hepatitis, tuberculose
  6. Severe allergy
  7. Autoimmune disease
  8. Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
  9. Uncontrolled hypercalcemia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978913

Contacts
Contact: Inge Marie Svane, prof.MD +4544884488 imsv@heh.regionh.dk
Contact: Lotte Engell-Nørregård, MD +4544884488 loteng02@heh.regionh.dk

Locations
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   
Sponsors and Collaborators
Herlev Hospital
Investigators
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
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Skin Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014