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

Ovarian Cancer Clinical Trial

Official title:

Vaccination of Patients Who Have Ovarian, Fallopian Tube or Peritoneal Cancer With Glycosylated MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS-21

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006041
• Other study ID #: 99-121
• Secondary ID: CDR0000068056NCI
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2000
• Last updated: June 17, 2013
• Start date: February 2000
• Est. completion date: February 2002

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells.

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

Description:

OBJECTIVES: I. Determine the safety of immunization with glycosylated MUC-1-KLH vaccine plus adjuvant QS21 in patients with ovarian, fallopian tube, or peritoneal epithelial cancer. II. Determine the dose of this treatment regimen for optimal antibody response in these patients. III. Determine the effect of immunization with this treatment regimen on the T-cell response in these patients.

OUTLINE: This is a dose escalation study of glycosylated MUC-1-KLH vaccine. Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3, 7, and 19. Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined. Patients are followed at 2 and 12 weeks, and then every 3 months thereafter as long as detectable immunity against MUC-1 persists.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed ovarian, fallopian tube, or peritoneal epithelial cancer (any stage at diagnosis) Prior cytoreductive surgery required Refractory or recurrent after at least one prior regimen of platinum based chemotherapy No evidence of disease following salvage chemotherapy, defined as: CA125 less than 35 units Negative physical examination No evidence of disease on CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin, SGOT, and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: No other concurrent active invasive malignancy No seafood allergy No positive stool guaiac (excluding hemorrhoids)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• MUC1-KLH conjugate vaccine

• MUC1-KLH vaccine/QS21

• QS21

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,