Intratumoral Application of L19IL2 in Patients With Malignant Melanoma

NCT01253096 | Completed Phase 2

• 1 other identifier: PH-L19IL2-03/09
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 3

Brief Summary

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.

Conditions

Malignant Melanoma

Keywords

Interleukin; IL2; monoclonal; antibody; cytokine; metastatic; melanoma; tumor targeting; intratumoral; Malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV without visceral metastases.

Outcome Measures

Primary Outcomes (1)

• Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 .

  week 12

Secondary Outcomes (7)

• Safety of intratumoral administration of L19IL2

  1-29 days

• Rate of patients with complete response (CR), partial response (PR) and stable disease (SD) of L19IL2 treated Index/Non-Index lesions at week 12.

  week 12

• Duration of objective response and disease control of L19IL2 treated Index/Non-Index lesions

  week 6-46

• Overall survival (OS)

  1 year

• Rate of patients with complete response (CR), partial response (PR) and stable disease (SD)of all metastases

  week 12

Study Arms (1)

L19IL2

EXPERIMENTAL

Drug: Intratumoral injections of L19IL2

Interventions

Intratumoral injections of L19IL2 DRUG

Patients will be treated with intratumoral injections of L19IL2 1-3 x weekly. The maximum cumulative dose per week is 20 MioIU. Treatment duration is up to 20 weeks.

L19IL2

Eligibility Criteria

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

You may qualify if:

• Histopathologically proven malignant melanoma.
• Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a.
• Males or females, age \>/= 18 years.
• Either without, or after one line of prior systemic treatment for metastatic disease.
• ECOG performance status \< 2.
• LDH \< 2 x the upper limit of normal.
• Life expectancy of at least 12 weeks.
• Absolute neutrophil count \> 1.5 x 10\^9/L.
• Hemoglobin \> 9.0 g/dL.
• Platelets \> 100 x 10\^9/L.
• Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl).
• ALT and AST ≤ 2.5 x the upper limit of normal (ULN) (5.0 x ULN for patients with hepatic involvement with tumor).
• Serum creatinine \< 1.5 x ULN.
• All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.02) Grade ≤ 1 unless otherwise specified above.
• Negative serum pregnancy test (for women of child-bearing potential only) at screening.

You may not qualify if:

• Primary ocular melanoma.
• Presence of visceral metastases at screening.
• Evidence of active brain metastases at screening.
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated \< 5 years prior to study entry.
• History of HIV infection or infectious hepatitis B or C.
• Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
• History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• Inadequately controlled cardiac arrhythmias including atrial fibrillation.
• Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria).
• Uncontrolled hypertension.
• Ischemic peripheral vascular disease (Grade IIb-IV).
• Severe diabetic retinopathy.
• Active autoimmune disease.
• History of organ allograft or stem cell transplantation.
• Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (3)

Universitätsklinik Graz

Graz, Austria

Location

Medizinischen Hochschule Hannover

Hanover, Germany

Location

University Hospital

Tübingen, Germany

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

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

Study Officials

• Claus Garbe, Prof. M.D.

  University Hospital Tuebingen (Germany)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

AU (1); DE (2)