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Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients (MIMOSA)

Primary Purpose

Ovarian Cancer

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abagovomab

Placebo

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Abagovomab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria:

Age >/= 18 years;
Properly executed written informed consent;
History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer;
History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy;
Complete clinical response defined as:
Normal physical examination;
No symptoms suggestive of persistent cancer;
No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks;
Negative chest x-ray (or chest CT scan) within the previous 4 weeks;
Serum CA125 within the normal laboratory range.
Adequate hematologic, renal and hepatic function:
- Absolute Neutrophil Count (ANC) >/=1.5 * 109/l;
- Platelets >/= 75 * 109/l;
- Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl);
- Serum creatinine </= 1.5 * ULN (Upper Limit of Normal);
- Bilirubin </= 1.5 * ULN; AST, ALT, AP </= 2.5 * ULN.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) </= 2.

Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are present:

any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);
known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);
known infection with hepatitis B, or hepatitis C;
history of recent myocardial infarction (</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class >/= III);
previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy.
concomitant use of any other investigational agent;
any prior investigational anti-cancer vaccine or monoclonal antibody;
known allergy to murine proteins;
any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
clinically significant active infection;
concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);
major surgery within the previous 2 weeks;
radiotherapy within the previous 4 weeks;
any significant toxicity from prior chemotherapy;
unreliability or inability to follow protocol requirements;
potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period;
pregnancy.

Sites / Locations

Cedars-Sinai Medical Center
University of California, Los Angeles (UCLA)
Stanford University
University of Colorado
University of Connecticut Health Center
University of Miami
Florida Hospital Cancer Institute
Curtis and Elizabeth Anderson Cancer Institute
Indiana University Cancer Pavilion
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Beth Israel Deaconess Medical Center
Wayne State University
Washington University
The Cancer Care Center
Women's Cancer Center
Hackensack University Medical Center, Obstetrics and Gynecology Oncology
Roswell Park Cancer Institute
Memorial Sloan-Kettering Cancer Centre
Duke University Medical Center
University of Pittsburgh
Women and Infants Hospital of Rhode Island
The West Clinic
Algemeen Stedelijk Ziekenhuis Aalst
Cliniques Universitaires Saint-Luc
Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
CHU de Liége (Sart Tilman)
Clinique Sainte Elizabeth
AZ Sint Augustinus, Oncologisch Centrum GVA
Fakultni nemocnice Brno
MOU Zluty Kopec
Nemocnice Ceske Budejovice, a.s.
Fakultni nemocnice Hradec Kralove
Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
Fakultni nemocnice Olomouc
Fakultni Nemocnice Ostrava
Krajska nemocnice
Gynekologicko-porodnicka klinika FN Plzen
Vseobecna Fakultni Nemocnice
Fakultni nemocnice Bulovka
Fakultni nemocnice Královské Vinohrady
Krajska nemocnice T. Bati
Institut Bergonié
Centre Jean Bernard
Centre Catherine de Sienne
Hôpital Hotel Dieu
Helios Kliniken GmbH, Klinikum Buch
Charité - Campus Virchow Klinikum
Universitätsklinikum Bonn
Klinikum Bremen-Mitte gGmbH
Klinikum Chemnitz GmbH
St.-Josefs-Hospital Cloppenburg
Universitätsklinikum Carl Gustav Carus Dresden
Evangelisches Krankenhaus
Kreisklinik Ebersberg gGmbH
Universitätsklinikum Erlangen
Universitätsklinikum
Klinikum der JWG Universität Frankfurt
Universitätsklinikum
Klinikum der Ernst-Moritz-Universität
Universitätsklinikum
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
Universitätskrankenhaus Hamburg-Eppendorf
Medizinische Hochschule Hannover
Universitätsklinikum Jena
St. Vincentius Kliniken AG
Klinikum Kassel
Universitätsklinikum Schleswig-Holstein Campus Kiel
Klinikum der Universität zu Köln
Kreiskrankenhaus Leonberg
Asklepios Klinik Lich
Vincenz-Krankenhaus
Klinik St. Marienstift
Städtisches Klinikum Magdeburg
Otto-von-Guericke-Universität
Johannes-Gutenberg-Universität
Universitätsklinikum Gießen u. Marburg
Klinikum der Universität München-Innenstadt
Klinikum Großhadern
Klinikum rechts der Isar
Klinikum Offenbach GmbH
St. Vincenz-Krankenhaus Paderborn
Elblandkliniken Meißen-Radebeul GmbH
Krankenhaus St. Josef
Klinikum Südstadt der Hansestadt Rostock
Universitätsklinikum Tübingen
Universitätsklinikum
Klinikum der Stadt Villingen-Schwenningen GmbH
St. Josefs-Hospital
r. Horst Schmidt Kliniken GmbH
Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg
Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia
Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika
Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika
Petz Aladar Megyei Oktató Kórház, Onkoradiológia
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály
Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika
Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály
Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico
Ospedale S. Orsola Malpighi, Oncologia Medica
Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia
DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini
Oncologia Medica Ospedale di Faenza - AUSL di Ravenna
Azienda Ospedaliera - Universitaria Careggi
Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
Istituto Nazionale dei Tumori di Milano
Istituto Europeo di Oncologia - Divisione di Ginecologia
Policlinico di Modena, Dipartimento di Oncologia ed Ematologia
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
Azienda Ospedaliera San Carlo - Oncologia Medica
Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica
Arcispedale Santa Maria Nuova, Oncologia Medica
Policlinico Umberto I D.H. Oncologico Oncologia Medica
Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli
Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia
Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna
Wojewódzki Szpital Specjalistyczny Nr 4
Oddzial Onkologii Wojewódzki Szpital Specjalistyczny
Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Vesalius Kraków
"Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,
Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny
Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu
SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii
Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej
Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON
Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych
Hospital Germans Trias y Pujol
Hospital Vall d'Hebrón, Servicio de Oncologia
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
Hospital Reina Sofia
Hospital de Elche, Servico de Oncologia
Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica
Hospital Virgen de las Nieves
Hospital Juan Ramón Jiménez de Huelva
Complejo Hospitalario de Jaén
Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
MD Anderson Internacional Espana
Hospital Clinico San Carlos, Servicio de Oncología Medica
Hospital de Mataró
Hospital Clinico de Malaga. Servicio de Oncologia
Hospital Central de Asturias
Hospital Son Llatzer
Hospital Son Dureta, Servicio de Oncología
Hospital Clínico Universitario de Santiago de Compostela
Hospital Universitario Virgen del Rocio
Hospital General Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abagovomab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)

The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.

Secondary Outcome Measures

Overall Survival

2 years survival rate

Safety

Safety was analyzed in all patients who received at least 1 dose administration. Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed.

Time Course of Immunoresponse

Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).

Full Information

NCT ID

NCT00418574

First Posted

January 4, 2007

Last Updated

November 17, 2011

Sponsor

Menarini Group

1. Study Identification

Unique Protocol Identification Number

NCT00418574

Brief Title

Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients

Acronym

MIMOSA

Official Title

A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Terminated

Why Stopped

No benefit on primary end point (RFS); no rationale to collect survival data

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Menarini Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

Detailed Description

Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy which in the vast majority of cases achieves the disappearance of ovarian cancer lesions. This status, called "clinical remission" which means having no evidence of cancer on CT scan or physical examination needs to be carefully follow up in order to confirm the maintenance of the remission status or to early detect if the cancer grows again and then start a new chemotherapy. At present, no approved therapies exist for the maintenance treatment of patients who achieved the clinical remission. This trial aims to evaluate if the repeated vaccination with Abagovomab creates an immunoresponse which is able to fight the cancer cells thus keeping the remission status as long as possible and help patients live disease-free and longer. Patients who achieve the remission status after chemotherapy will be screened for study participation and if they meet the criteria for inclusion they will start to receive a single subcutaneous injection every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase). The duration of treatment is up to approximately 4 years or it will be stopped in case relapse occurs. In order to evaluate the real benefit of vaccination, the experimental treatment includes Abagovomab (the active drug) or placebo (the vehicle only, without drug), with a double chance to receive Abagovomab. Assignment of Abagovomab or placebo will be done by a computerised system and nobody in the study will know which treatment has been allocated until study end. Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every 12 weeks in order to confirm the remission status or to early detect if relapse eventually occurs. This will be done in blind condition (i.e. without being aware which treatment the patient is going to receive) for the first part of the study which is expected to last four years. After then the overall status of patient will continue to be monitored by phone contact for additional five years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Ovarian cancer, Abagovomab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

888 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abagovomab

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Abagovomab

Intervention Description

2 mg/ml SC (subcutaneously)

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

2 mg/ml SC (subcutaneously)

Primary Outcome Measure Information:

Title

Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)

Description

Time Frame

Every 12 weeks up to recurrence or up to 3 months after last administered dose

Secondary Outcome Measure Information:

Title

Overall Survival

Description

2 years survival rate

Time Frame

2 years

Title

Safety

Description

Time Frame

Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose

Title

Time Course of Immunoresponse

Description

Time Frame

at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria: Age >/= 18 years; Properly executed written informed consent; History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy; Complete clinical response defined as: Normal physical examination; No symptoms suggestive of persistent cancer; No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks; Negative chest x-ray (or chest CT scan) within the previous 4 weeks; Serum CA125 within the normal laboratory range. Adequate hematologic, renal and hepatic function: Absolute Neutrophil Count (ANC) >/=1.5 * 109/l; Platelets >/= 75 * 109/l; Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl); Serum creatinine </= 1.5 * ULN (Upper Limit of Normal); Bilirubin </= 1.5 * ULN; AST, ALT, AP </= 2.5 * ULN. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) </= 2. Exclusion Criteria: Patients are ineligible to participate in the study, if any of the following criteria are present: any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy; known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.); known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.); known infection with hepatitis B, or hepatitis C; history of recent myocardial infarction (</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class >/= III); previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy. concomitant use of any other investigational agent; any prior investigational anti-cancer vaccine or monoclonal antibody; known allergy to murine proteins; any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; clinically significant active infection; concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.); major surgery within the previous 2 weeks; radiotherapy within the previous 4 weeks; any significant toxicity from prior chemotherapy; unreliability or inability to follow protocol requirements; potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period; pregnancy.

Overall Study Officials: