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Multivalent Conjugate Vaccine Trial for Patients With Biochem. Relapsed Prostate Cancer

NCT00579423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-05

No results posted yet for this study

Summary

This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer.

Conditions

Interventions

BIOLOGICAL

QS21

* Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug. * Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs. * Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient.

Sponsors & Collaborators

Principal Investigators

  • Susan Slovin, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2003-05-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00579423 on ClinicalTrials.gov