Cancer Clinical Trial - Multivalent Conjugate Vaccine Trial for Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. This trial is based on the results of eight dose-seeking phase I monovalent glycoprotein and carbohydrate conjugate vaccine trials in a patient population with minimal tumor burden despite a rising biomarker, PSA, who have failed primary therapy such as surgery or radiation. We know that a rising PSA is indicative of micrometastatic disease - a state to which the immune system may maximally respond. Based on these trials, we have identified three glycolipid antigens, Globo H, Lewisy and GM2 and three mucin antigens, glycosylated MUC-1, Tn(c), and TF(c) for inclusion into a multivalent trial. As a result of these vaccinations, most patients generated specific high titer IgM and IgG antibodies against the respective antigen-KLH conjugates. Our previous work has shown the monovalent vaccines to be safe with local erythema and edema but minimal systemic toxicities. Our data from approximately 160 men who participated in our earlier monovalent vaccine trials against the aforementioned antigens have shown that a treatment effect in the form of a decline in PSA log slopes compared with pretreatment values could be seen in patients with minimal tumor burden. The multivalent vaccine will consist of the lowest dose of synthetic glycoprotein and carbohydrate antigens shown to elicit high titer IgM and IgG antibodies in patients with biochemically relapsed prostate cancer. A phase III double blind randomized trial with two hundred forty patients is planned based on the safety and immunogenicity data accrued from this pilot trial. The primary endpoints of this study will be the safety of the vaccine and the humoral response to each of the antigens. The secondary endpoint will be to evaluate post-therapy changes in PSA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00579423
Study type	Interventional
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	November 2000
Completion date	March 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05346796` - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial	N/A
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT04867850` - Effect of Behavioral Nudges on Serious Illness Conversation Documentation	N/A
Enrolling by invitation	`NCT04086251` - Remote Electronic Patient Monitoring in Oncology Patients	N/A
Completed	`NCT01285037` - A Study of LY2801653 in Advanced Cancer	Phase 1
Completed	`NCT00680992` - Study of Denosumab in Subjects With Giant Cell Tumor of Bone	Phase 2
Completed	`NCT00062842` - Study of Irinotecan on a Weekly Schedule in Children	Phase 1
Active, not recruiting	`NCT04548063` - Consent Forms in Cancer Research: Examining the Effect of Length on Readability	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT04349293` - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways	N/A
Terminated	`NCT02866851` - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy	N/A
Active, not recruiting	`NCT05304988` - Development and Validation of the EFT for Adolescents With Cancer
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT00340522` - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Terminated	`NCT01441115` - ECI301 and Radiation for Advanced or Metastatic Cancer	Phase 1
Recruiting	`NCT06206785` - Resting Energy Expenditure in Palliative Cancer Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms