Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy

NCT00918593 | Withdrawn Phase 2 DMC

• 2 other identifiers: AA0906EudraCT number: 2009-011455-51
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

Conditions

Ulcerated Cutaneous Metastases

Keywords

Metastases; Cutaneous; Ulcerating; Palliative; ulcerating metastases

Outcome Measures

Primary Outcomes (1)

• Safety and response

  30 days

Secondary Outcomes (2)

• patient satisfaction

  180

• Economics

  180 days

Study Arms (2)

Electrochemotherapy

EXPERIMENTAL

Drug: Electrochemotherapy; Drug: Bleomycin

radiotherapy

ACTIVE COMPARATOR

Radiation: Radiotherapy

Interventions

Electrochemotherapy DRUG

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Also known as: ECT

Electrochemotherapy

Radiotherapy RADIATION

Radiotherapy according to hospital procedures.

Also known as: RT

radiotherapy

Bleomycin DRUG

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Electrochemotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18.
• Histological proven cancer, any histology.
• Progressive and/or metastatic disease.
• One or more ulcerating cutaneous metastases.
• Patient in need of palliation of the ulcerating metastases.
• Lesion to be treated between 1 cm - 5 cm in diameter.
• Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy.
• WHO performance ≤ 2.
• Life expectancy of at least 3 months.
• Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.
• Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
• Written informed consent must be obtained according to the local Ethics committee requirements.

You may not qualify if:

• Previous electrochemotherapy or radiotherapy in the area to be treated
• Acute lung infection
• Previous bleomycin treatment exceeding 200.000 Units/m2.
• Known hypersensitivity to any of the components of the treatment.
• Known hypersensitivity to any of the components used in the planned anaesthesia.
• Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
• Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
• Creatinine measurements over 150 micromolar will require Crohm-EDTA clearance. Crohm-EDTA below 48 ml/minute
• Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Copenhagen University Hospital at Herlev

Herlev, Copenhagen, 2730, Denmark

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Ulcer

Interventions

Electrochemotherapy; Radiotherapy; Bleomycin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Julie Gehl, Consultant

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

DK (1)