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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00006041
First received: July 5, 2000
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: February 2000
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006041

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006041     History of Changes
Other Study ID Numbers: 99-121, CDR0000068056, NCI-H00-0060
Study First Received: July 5, 2000
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
QS 21
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014