Clinical trial NCT00058435: Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Official title: Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer

  * Stage II-IV
* Initially treated with surgery and at least 1 platinum-based chemotherapy regimen
* Must have relapsed after initial treatment and completed chemotherapy for recurrent disease
* Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed
* Complete clinical remission allowed, defined by the following criteria:

  * CA 125 no greater than 35 IU/mL
  * No objective evidence of disease by CT scan
  * Normal physical examination

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* At least 3 months

Hematopoietic

* WBC at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

* Bilirubin no greater than 2 times normal
* ALT no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal

Renal

* Creatinine no greater than 1.5 times normal

Other

* Not pregnant or nursing
* No potential for child bearing
* Human antimurine antibody negative
* HIV negative
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No active infection
* No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)
* No known immune deficiency (e.g., hypogammaglobulinemia)
* No known allergy to murine proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 6 weeks since prior interferon
* At least 6 weeks since prior immunotherapy or biological response modifiers
* No prior anticancer vaccine

Chemotherapy

* See Disease Characteristics
* At least 3 weeks since prior cytotoxic or investigational chemotherapy

Endocrine therapy

* No concurrent steroids

Radiotherapy

* At least 4 weeks since prior radiotherapy

Surgery

* See Disease Characteristics

Other

* At least 1 week since prior antibiotics
* No concurrent cyclosporine
* No other concurrent immunosuppressive therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Sabbatini, MD
role: STUDY_CHAIR
References: