Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Paul Sabbatini, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
02-122
NCT ID:
NCT00058435
Start Date:
December 2002
Completion Date:
March 2004
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- 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
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
