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


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

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 CenterNew York, New York  10021