mRNA Electroporated Autologous Dendritic Cells for Stage III/IV Melanoma

NCT01676779 | Completed Phase 2

• 1 other identifier: DC-MEL
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, 2-arm, 1-stage, randomized controlled phase II study in patients with AJCC stage IIIB/C \& -IV melanoma. At baseline tumor assessment (using total body FDG-PET/CT), patients should be free from measurable tumor lesions (according to RECISTv1.1 definitions) following prior local therapy (e.g. following surgical resection, isolated limb perfusion, radiofrequency ablation, cryotherapy, radiotherapy, electrochemotherapy, …). Patients should not have symptomatic non-measurable tumor lesions (e.g. bone metastasis, or pleural effusion), and lesions treated by prior local therapy should be free from progression. Patients should not have received any prior systemic therapy (non-experimental or experimental).

Conditions

Malignant Melanoma Stage III; Malignant Melanoma Stage IV

Keywords

melanoma; no evidence of disease; resection; macro-metastases

Outcome Measures

Primary Outcomes (1)

• 1-year disease free survival percentage

  Patients will be evaluated 52 weeks following randomization for their melanoma disease status (= macro-metastases present or absent)

  1-year following recruitment date

Secondary Outcomes (1)

• safety

  continuous during the study (52weeks after start)

Study Arms (2)

Arm A dendritic cell therapy

EXPERIMENTAL

Arm-A, patients will receive Dendritic Cell therapy during one year following randomization.

Biological: Dendritic cell therapy

Arm B Dendritic cell therapy

EXPERIMENTAL

Arm-B, patients will initiate Dendritic Cell therapy only after documented recurrence of the melanoma that cannot be salvaged by local therapy.

Biological: Dendritic cell therapy

Interventions

Dendritic cell therapy BIOLOGICAL

Dendritic cell therapy IV and ID

Arm A dendritic cell therapy; Arm B Dendritic cell therapy

Eligibility Criteria

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

You may qualify if:

• Able and willing to give written informed consent
• Histological documentation of AJCC stage III or stage IV melanoma
• melanoma (melanoma originating in the choroid, iris or ciliar body are not eligible)
• baseline tumor assessment by whole-body FDG-PET/CT, patients should be free from measurable tumor lesions (RECIST (v1.1)), and free from symptomatic non-measurable tumor lesions
• Prior local treatment of primary and metastatic tumor lesions is allowed . Treated tumor lesions should be free from progression at baseline assessment
• Normal organ function and normal hematological parameters;laboratory parameters should be within normal range, except following laboratory parameters:HEMOGLOBIN ≥ 10 G/DL; GRANULOCYTES ≥ 1,500/µL; LYMPHOCYTES ≥ 1000/µL; PLATELETS ≥ 100,000/µL; SERUM CREATININ ≤ 2.0 MG/DL; SERUM BILIRUBIN ≤ 2.0 MG/DL; AST AND ALT ≤ 2 X THE NORMAL UPPER LIMITS; LDH ≤ 1,5X NORMAL UPPER LIMIT; CRP ≤ 1,5X NORMAL UPPER LIMIT; PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) AND PARTIAL THROMBOPLASTIN TIME (PTT) WITHIN NORMAL LIMITS
• Negative serology for HCV, and HIV; absence of active infection with HBV, and Syphilis; If positive results for HepB or Syphilis indicate immunity and are not indicative of active infection, the patient can enter the study.
• Adequate venous access(to undergo leukapheresis)
• No prior systemic therapy for melanoma
• Full recovery from all prior therapies. A period of 4 weeks following major surgery, radiation therapy, or ILP, or any other major invasive procedure is required
• Baseline WHO performance status of 0 or 1
• Male and female patients ≥ 18 years
• No need for uninterrupted therapeutic anticoagulation
• No prior history of a serious autoimmune disorder
• No concomitant medication with immune suppressive drugs

You may not qualify if:

• Any serious acute or chronic illnesses (e.g. heart disease NYHA Class III or IV,renal-,liver- or pulmonary insufficiency) or other conditions requiring concurrent medications not allowed during this study (e.g. active chronic infections requiring antibiotics)
• History of malignancy. Curatively treated cervical carcinoma in situ,or squamous-,or basal cell carcinoma of the skin, or subjects who have been treated and recurrence-free of other malignancies for more than 5 years following the diagnosis are eligible
• Inability to undergo FDG-PET/CT, or MRI examination
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment
• Subject is pregnant (positive serum beta-HCG test at screening) or is currently breast-feeding, anticipates becoming pregnant/impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment
• Current alcohol dependence or drug abuse
• Known hypersensitivity to the study treatment
• Legal incapacity or limited legal capacity
• Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Signs and symptoms suggestive of transmissible spongiform encephalopathy,or family members who suffer(ed) from such.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• RIZIV: collaborator

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Bart Neyns, Phd Md

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of devision (Medical Oncology)

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 31, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

BE (1)