Symptoms and General Pathology

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Fallopian Tube Cancer

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Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Vaccines

Immunoglobulins

Antibodies, Anti-Idiotypic

Immunoglobulin Idiotypes

Abagovomab

Antineoplastic Agents, Immunological

abagovomab

Paul Sabbatini, MD

RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.

OBJECTIVES:

* Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.
* Determine an optimal dose and route of this vaccine for a phase II study.
* Determine the immune response induced by this vaccination in these patients.
* Determine the time to development of objective tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.
* Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
* Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.

Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Immunomodulating Agents

Placebo

Jacobus Pfisterer, MD

Jonathan Berek, MD

Giovanni Scambia, MD

Antonio Casado, MD

Anna Pluzanska, MD

Karel Cwiertka, MD

Tamás Pintér, MD

Eric Pujade-Lauraine, MD

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.

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.

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

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

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.

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 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).

Menarini Group

Adverse Events monitored throughout the observation period, at each visit prior dosing (every 2 weeks during the induction phase, every 4 weeks during the maintenance phase)

2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)

Total

Age, Categorical

Age Continuous

Female

Sex/Gender, Customized

France

United States

Hungary

Czech Republic

Poland

Spain

Belgium

Germany

Italy

Region of Enrollment

Serous/papillary

Endometrioid

Mucinous

Undifferentiated

Mixed tumor

Others

missing

Histology of ovarian tumor

This scale and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale runs from the score 0 to 5, with 0 denoting the status "Fully active, able to carry on all pre-disease performance without restriction" and 5 the status "Dead".

Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

G1-G2

G3-G4

not done

Histologic grade, also called differentiation, refers to how much the tumor cells resemble normal cells of the same tissue type.

GX Grade cannot be assessed (Undetermined grade) G1 Well-differentiated (Low grade) - best prognosis G2 Moderately differentiated (Intermediate grade) G3 Poorly differentiated (High grade) G4 Undifferentiated (High grade) - worst prognosis

Grade of histologic differentiation

International system of staging which identifies the spread of the ovarian cancer at the point of diagnosis \[STAGE 1 - Tumour is confined to the ovary / ovaries; STAGE 2 - Tumour involves one or both ovaries and has extended into the pelvis; STAGE 3 - The tumour involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis, includes liver capsule metastasis; STAGE: 4 - Distant metastasis beyond the peritoneal cavity, liver parenchymal metastasis.\]

International Federation of Gynecology and Obstetrics (FIGO) stage

<= 1 cm

> 1 cm

Tumor size after debulking surgery

<= 35 U/ml

> 35 U/ml

Serum CA-125 after 3rd chemotherapy cycle

Clinical Research Director

intention to treat (ITT) population (i.e. all randomized patients)

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

Overall Survival

Patients with at least 1 Adverse Event (AE)

Patients with at least 1 Adverse Drug Reaction ADR

Patients with at least 1 Serious Adverse Event SAE

Patients with at least 1 Serious ADR (SADR)

Patients with at least 1 AE leading to withdrawal

Patients with at least 1 AE resulted in death

Safety population (i.e. All randomized patients who received at least one dose treatment administration)

Safety

Ab3 (baseline)

Ab3 (week 10)

Ab3 (end of treatment)

Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit

Time Course of Immunoresponse

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer	NCT00058435	Fallopian Tube ... Ovarian Cancer Primary Periton...	abagovomab	18 Years -	Memorial Sloan Kettering Cancer Center
Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients	NCT00418574	Ovarian Cancer	Abagovomab Placebo	18 Years -	Menarini Group
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer	NCT00058435	Fallopian Tube ... Ovarian Cancer Primary Periton...	abagovomab	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for abagovomab

Every month we try and update this database with for abagovomab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abagovomab

Every month we try and update this database with for abagovomab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abagovomab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.