Cell based immune therapy for patients with skincancer

Phase 1

• Conditions: malignant melanoma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 18.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2014-001420-29-DK
• Lead Sponsor: Center for Cancer Immune Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Histologically confirmed metastatic or locally advanced malignant melanoma
- Patients must have a resectable lesion
- Patients must be between 18 years and 70 years of age and must have measurable disease
- Patients must have a clinical performance status of ECOG 0 or 1.
- Adequate organ function
- Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for six months after receiving the preparative regimen.
- Patients must be able to understand and sign the Informed Consent document.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Patients with other cancers within 5 years
- Patients with ocular melanoma
- Serious comorbity or autoimmune disease
- Requirement for immunosuppressive doses of systemic corticosteroids or other immunosuppressive drugs
- Patients who have any CNS lesion that is symptomatic or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 1 month.
- Other anticancer treatment within 28 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified