188Re-marked Ior C5 MAb in persistent or relapsing ovary epithelial cancer, phase I.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Radio immunotherapy with 188Re-marked Ior C5 MAb in patients with persistent or relapsing ovary epithelial cancer, phase I.

Secondary indentifying numbers:

IIC RD-EC 082

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government Funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

18/07/2006

Reference number:

1288/05.014.05B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juan

Midle name:

Felipe

Last name:

Batista Cuellar

Affiliation:

Clinical Research Center

Postal address:

Calle 45 No. 4501, esquina a 34, Reparto Kholy

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72030087

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Clinical Research Center Hospital (CIC) December 2th,2004.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/01/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Persistent or relapsing ovary epithelial cancer

Health condition(s) code:

Ovarian Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine Gland Neoplasms

Adnexal Diseases

Ovarian Diseases

Genital Diseases, Female

Female Urogenital Diseases

Gonadal Disorders

Endocrine System Diseases

Intervention(s):

Scheme used for scaling-up dosage of 188Re/Ior C5 MAb. 188Re/Ior C5 MAb will be administered 7 to 14 days after diagnosis study is completed. One single 3-5mg dose of MAb will be given transperitoneally in an area close to Gamma chamber. Five groups will be included in the study, namely: Group 1: 3-5 mg of Ior c5 MAb - 5 mCi/m2 Group 2: 3-5 mg of Ior c5 MAb - 10mCi/m2 Group 3: 3-5 mg of Ior c5 MAb - 16.7 mCi/m2 Group 4: 3-5 mg of Ior c5 MAb - 25.05mCi/m2 Group 5: 3-5 mg of Ior c5 MAb - 33.3 mCi/m2

Intervention code:

Immunoconjugates

Antibodies, Monoclonal

Antibodies

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Maximum permissible dose and toxicity, measuring time: 12 months.

Key secondary outcomes:

Adverse events, pharmacokinetics, biodistribution, dosage, HAMA effect, immunogenicity, antitumoral effect, measuring time: 12 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

70 years

Inclusion criteria:

1) Patients who have previously been on well established onco-specific treatments and therapies. 2) Patients giving their consent in writing to participate in the trial. 3) Patients whose previous immunogammagraphic studies with 99mTc-iorc5 (7-14 days before treatment) showed positive images and 4-quadrant permeability. 4) Patients aged 18 to 70. 5) Karnofsky Coefficient = 60. 6) Patients whose life expectancy is > 3 months. 7)Patients with organs and bone marrow working normally, in keeping with the following parameters: Hemoglobin >= 10 g/L, Total leucocytes >= 4x109 cells/L, Absolute neutrophil count >= 1,500/uL, Platelet count >= 100x109/L, Total bilirubin: within normal limits, TGP and TGO: = 2.5 times the institutional higher normal value, Serum creatinine = 132mmol/L, Urea and Glycemia: within normal limits for each institution. 8) Female patients will be included in the trial.

Exclusion criteria:

1) Pregnancy and/or breastfeeding. 2) Patients with severe acute diseases. 3)Patients on previous abdominal radiant therapy preventing the immunogammagraphic study with 99mTc-ior c5 for 4-quadrant permeability confirmation. 4) Patients on another concurrent onco-specific treatment (PQT, external radiotherapy, immunotherapy, etc.). 5) Patients with another concomitant cancer. 6) Patients with fever due to acute infectious diseases. 7)Patients with history of severe allergies or uncontrolled chronic diseases, such as ischemic cardiopathy, bronchial asthma, diabetes mellitus, high blood pressure, etc. 8) Patients who have previously been on murine MaB therapy. 9) Coagulation disorders. 10) Local sepsis in the area to be treated.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dosis escalation

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224.

Email :

casaco@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Angel

Middle Name:

Raimundo

Last Name:

Casaco Parada

Specialty:

Specialist 2nd Grade in Normal and Pathological Physiology

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana city

País:

Cuba

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 224

Email :

casaco@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000036

Date of Registration in Primary Registry:

2010-12-27

Record Verification Date:

2008-01-23 19:00

Link to the spanish version:

Click here [3]