Know Cancer

or
forgot password

A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Patients With Cancer

Thank you

Trial Information

A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER


The L19SIP antibody is a fully human antibody, capable of preferential localization around
tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a
rare event in the adult (exception made for the female reproductive cycle), but is a
pathological feature of most aggressive types of cancer. The study aims at determining the
therapeutic potential of the L19SIP antibody in SIP format, labelled with the radionuclide
131I, for the treatment of patients with different cancer types. The study follows a Phase I
study performed with 131I-L19SIP in over 30 patients with cancer, which has shown an
excellent tolerability at radioactive doses as high as 150 mCi and therapeutic benefit for
some patients enrolled in the study.


Inclusion Criteria:



1. Patients with cancer, with progressive disease in pre-study period, refractory to
conventional standard treatments.

2. Histologically/cytologically confirmed diagnosis of cancer, preferably lung cancer,
prostate cancer and colorectal cancer (CRC). At least one measurable (minimum 2.0
cm), non irradiated lesion defined according to modified RECIST criteria, i.e.
whenever the measurable disease is restricted to a solitary lesion, its neoplastic
nature need not to be confirmed by cytology/histology.

3. ECOG performance status grade 0 or 1.

4. Age ≥18 and ≤ 75 years.

5. Adequate haematological, liver and renal function (haemoglobin ≥ 9 g/dL, absolute
neutrophil count (ANC) ≥ 1.50 x 10^9/L; platelets ≥ 100 x 10^9/L, bilirubin within
UNL; alkaline phosphatase≤ 2.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver
metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL.

6. All acute toxic effects (excluding alopecia) of any prior therapy (including surgery
radiation therapy, chemotherapy) must have resolved to National Cancer Institute
(NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) Grade ≤ 1.

7. Negative serum pregnancy test for females of childbearing potential within 14 days of
starting treatment.

8. If of childbearing potential, agreement to use adequate contraceptive methods (e.g.
oral contraceptives, condoms, or other adequate barrier controls, intrauterine
contraceptive devices, or sterilization) beginning at the screening visit and
continuing until 3 months following last treatment with study drug.

9. Evidence of a personally signed and dated IEC-approved Informed Consent indicating
that the patient (or legally acceptable representative) has been informed of all
pertinent aspects of the study.

10. Willingness and ability to comply with the scheduled visits, treatment plan,
laboratory tests and other study procedures.

11. Life expectancy of at least 3 months.

12. Signed and dated informed consent.

Exclusion Criteria:

1. Chemotherapy, radiation, hormonotherapy (with the exception of a gradual titration of
LHRH agonists) or immunotherapy or participation in any investigational drug study
within 4 weeks of study entry (6 weeks in case of prior nitroureas chemotherapy).

2. Prior radiation dose > 30% of bone marrow volume.

3. Presence of cirrhosis or active hepatitis.

4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II
NYHA, angina pectoris, myocardial infarction within one year prior to study entry,
uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.

5. Presence of uncontrolled intercurrent illness or any condition which in the judgement
of the investigator would place the subject at undue risk or interfere with the
results of the study.

6. Recovery from major trauma including surgery within 4 weeks of administration of
study treatment.

7. Pregnancy or lactation or unwillingness to use adequate method of birth control.

8. Active infection or incomplete wound healing.

9. Known history of allergy to intravenously administered proteins / peptides /
antibodies.

10. Any conditions that in the opinion of the investigator could hamper compliance with
the study protocol.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum tolerated dose (MTD)

Outcome Description:

Establishment of the maximum tolerated dose (MTD) and the recommended dose (RD) for the radiolabelled L19SIP monoclonal antibody.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Giuliano Mariani, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Pisa, Italy

Authority:

Italy: National Institute of Health (Istituto Superiore di Sanità)

Study ID:

PH-L19SIPI131-07/07

NCT ID:

NCT01242943

Start Date:

November 2008

Completion Date:

May 2011

Related Keywords:

  • Patients With Cancer
  • I131
  • L19
  • antibody
  • monoclonal
  • tumour targeting
  • radioimmunotherapy
  • cancer

Name

Location