Know Cancer

or
forgot password

A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT) in Patients With Multiple Brain Metastases From Solid Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Metastases From Solid Tumors

Thank you

Trial Information

A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT) in Patients With Multiple Brain Metastases From Solid Tumors


Inclusion Criteria:



- 6.3.1 Inclusion Criteria for Dosimetric Study Part (diagnostic 131I-L19SIP or
124I-L19SIP) and therapeutic study part

- Unresectable multiple brain metastasis from histologically or cytologically confirmed
solid tumors. In exceptional cases also patients with a single brain metastasis if
not amenable for surgical treatment might be included.

- Males or females, age > 18 years

- Measurable disease defined as at least one metastatic brain lesion that can be
accurately and serially measured by the modified RECIST criteria (version 1.1)

- Prior therapy for metastatic disease allowed

- RPA Class II

- Life expectancy of at least 12 weeks

- Serum creatinine < 1.5 x ULN

- All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise
specified above

- Negative serum pregnancy test (for women of child-bearing potential only) at
screening

- If of childbearing potential, agreement to use highly effective contraceptive methods
(e.g., established use of oral, injected or implanted hormonal methods, placement of
intrauterine device or intrauterine system, use of condom or occlusive cap with
spermicidal foam/gel/film/cream/suppository, male sterilization or true abstinence)
beginning at the screening visit and continuing until 3 months following last
treatment with study drug.

- In case of treated males (including men who have had vasectomies) who have a partner
who is pregnant or of child-bearing potential, agreement to use condoms beginning at
the screening visit and continuing until 3 months following last treatment with study
drug.

- Patients with microhaemorrhage can be included if the microhaemorrhage does not
appear to significantly contribute to symptoms caused by the particular brain lesion
and if the microhaemorrhage does not appear to significantly contribute to a possible
mass effect of the brain lesion in question.

Additional Inclusion Criteria for Therapeutic Study Part

- Absolute neutrophil count > 1.0 x 109/L, hemoglobin > 8.0 g/dL (packed red cell
transfusions allowed), and platelets > 100 x 109/L

- Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dL). For patients with liver involvement
with tumor total bilirubin ≤ 45 µmol/L (or ≤ 3.0 mg/dL).

- ALT and AST ≤ 2.5 x the upper limit of normal (10 x ULN for patients with hepatic
involvement with tumor

Exclusion Criteria:

- Primary ocular melanoma

- Patients with brain metastasis amenable for surgical excision or stereotactic
irradiation (radiosurgery)

- 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

- Patients with history of whole brain irradiation

- 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.

- 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

- Pregnant woman

- Breast feeding female

- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6
weeks before administration of study treatment

- Growth factors or immunomodulatory agents within 7 days of the administration of
study treatment

- Patients in need of systemic treatment associated with a moderate or significant
potential of hematotoxicity for rapidly progressive systemic disease during study
treatment and up to 4 weeks after injection of therapeutic 131I-L19SIP.

- Hyperthyroidism or autonomous thyroid nodule

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Uptake of 131I-L19SIP or 124I-L19SIP

Outcome Description:

Selective uptake of 131I-L19SIP or 124I-L19SIP in brain lesions

Outcome Time Frame:

2 days

Safety Issue:

No

Principal Investigator

Secondo Lastoria, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI

Authority:

Italy: Ethics Committee

Study ID:

PH-L19SIPI131-01/09

NCT ID:

NCT01125085

Start Date:

October 2009

Completion Date:

May 2013

Related Keywords:

  • Brain Metastases From Solid Tumors
  • I131
  • L19
  • antibody
  • monoclonal
  • multiple brain metastasis
  • tumor targeting
  • radioimmunotherapy
  • Patients with brain metastases of solid tumors (>1), who are not amenable for surgical excision or stereotactic radiosurgery.
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms
  • Neoplasms

Name

Location