Cancer Center– A Cancer Center Designated by
the National Cancer Institute

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

Contact Information

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Fitzsimmons Colleen
(650) 724-3155
cfitzsimmons@stanford.edu

Recruiting Status: No longer recruiting

Stanford Recruiting Status: No longer recruiting

Investigator(s):

Description:

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.

Conditions Studied:

Lead Sponsor: Menarini Ricerche S.p.A.

Intervention(s):

Phase: Phase 2/Phase 3


Eligibility

Key Inclusion Criteria:

At a maximum of 8 weeks after the last cycle of 1st line standard platinum/taxane chemotherapy, patients must fulfil all the following inclusion criteria to be eligible for entry into the study:

- Age >= 18 years;

- Properly executed written informed consent;

- History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage IIIoIV epithelial ovarian, fallopian tube, or primary peritoneal cancer;

- History of debulking surgery and standard platinum/taxane based nonoinvestigational 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 xoray (or chest CT scan) within the previous 4 weeks;

- Serum CA125 level <= 35 U/ml.

- Adequate hematologic, renal and hepatic function:

o ANC >=1.5 x 109/l;

o Platelets >= 75 x 109/l;

o Haemoglobin >= 6.2 mmol/l (>9.9 mg/dl);

o Serum creatinine <= 1.5 x ULN;

o Bilirubin <= 1.5 x ULN; AST, ALT, AP <= 2.5 x ULN.

- ECOG Performance Status (PS) <= 2.

Key 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 (NYHA class >/= III);

- previous or concomitant use of any anti-cancer therapy other than the platinum-taxane 1st 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.

Ages Eligible for Study: 18 years to Any Age

Genders Eligible for Study: Female

Healthy Volunteers?: People with the conditions listed in this trial can not participate as controls.

Additional Study Details

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

Anticipated start date: 8/6/2007

Study Type: Interventional

Purpose: Treatment

Allocation: Randomized

Masking: Double Blind

Control: none

Assignment: Parallel

Endpoints: Unspecified

Primary Outcomes:

Secondary Outcomes:

Total Number to be Enrolled: 870

Total Number to be Enrolled at Stanford: 15


More Information

Publications About this Study:

Trial Unique Id: SU-07232007-629

Secondary ID(s)


Locations & Contacts
Stanford Locations & Contacts

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Fitzsimmons Colleen
(650) 724-3155
cfitzsimmons@stanford.edu

Non-Stanford Locations

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated: 8/18/2009

PLEASE NOTE: Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or email referral@medcenter.stanford.edu .

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