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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006041
Recruitment Status : Completed
First Posted : June 28, 2004
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Biological: MUC1-KLH conjugate vaccine Biological: MUC1-KLH vaccine/QS21 Biological: QS21 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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
Study Start Date : February 2000
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006041

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Paul Sabbatini, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00006041    
Other Study ID Numbers: 99-121
CDR0000068056 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 28, 2004    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Saponin QA-21V1
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic