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

NCT00978913 | Completed Phase 1 DMC

• 1 other identifier: AA 0914
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Malignant Melanoma

Keywords

dendritic cell; cancervaccine; breast cancer; malignant melanoma; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• to evaluate the toxicity of the vaccine in combination with Cyclophosphamide

  biweekly

Secondary Outcomes (3)

• to investigate the clinical tumor response and the duration

  after 12 weeks

• to evaluate the duration of tumor and immunoresponse

  3, 6, 9 months

• to evaluate immune response

  at 8 and 12 weeks

Study Arms (1)

DC vaccination and Cyclophosphamide

EXPERIMENTAL

Biological: DC vaccine

Interventions

DC vaccine BIOLOGICAL

DC vaccination, one vaccine biweekly

Also known as: dendritic cell vaccine, Cyclophosphamide, Sendoxan®, Baxter

DC vaccination and Cyclophosphamide

Eligibility Criteria

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

You may qualify if:

• 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
• \. At least one measurable lesion according to RECIST criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inge Marie Svane: lead

Study Sites (1)

Department of Oncology, Herlev University Hospital

Herlev, Dk 2730, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Inge Marie Svane, prof.MD

  Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: May 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

DK (1)