Clinical trial · Interventional
Multivalent Conjugate Vaccine Trial for Patients With Biochem. Relapsed Prostate Cancer
A Pilot Multivalent Conjugate Vaccine Trial for Patients With Biochemically Relapsed Prostate Cancer
NCT00579423CI-TRIAL-00070219completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QS21 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vaccine
- description
- Patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administrated at the standard dose of 100ug.
- interventionNames
- Biological: QS21
Primary outcomes (1)
- measure
- Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo.
- timeFrame
- 11/2000-12/2008
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with prostate cancer that is histologically confirmed. * Patients must show biochemical progression after primary therapy, including surgery or radiation (with or without neo-adjuvant androgen ablation). This detection of PSA following treatment must occur within two years. * Patients who have had intermittent hormonal treatment, following primary therapy, who have non-castrate levels of testosterone (\>50 ng/ml) are eligible. Hormonal status will be recorded on the basis of serum testosterone levels. * Karnofsky performance status \>60%. * Patients must have adequate organ function as defined by: 1. WBC \> or = to 3500/mm3, platelet count \> or = to 100,000 mm3. 2. Bilirubin \<2.0 mg/100 ml or SGOT \<3.0 X's the upper limit of normal. 3. Creatinine \< or = to 2.0 mg/100 ml or creatinine clearance \> or = to 40 cc/min. * Patients must have recovered from the toxicity of any prior therapy, and not received chemotherapy or radiation therapy for at least 4 weeks prior to entry into the trial. * No history of an active secondary malignancy within the prior five years except for nonmelanoma skin cancer. Patients with history of melanoma in situ will be permitted since these lesions behave in a manner similar to compound nevi. * Patients must be at least 18 years of age. * Patients must sign informed consent. Exclusion Criteria: * Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease. * Radiographic evidence of metastatic disease. * An infection requiring antibiotic treatment. * Narcotic dependent pain. * Anticipated survival of less than 6 months. * Positive stool guaiac excluding hemorrhoids or history of documented radiation induced proctitis. * Allergy to seafood. * Prior vaccine therapy at outside institution except for phase I monovalent trial performed at MSKCC.
References
Publications (0)
Data not yet available
No reference posted for this study.