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Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)

NCT00961376 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-08-28

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and immunologic effects of autologous tumor vaccination administered with human granulocyte-macrophage colony-simulating factor (hGM-CSF), and subsequent boosting vaccinations in patients made lymphopenic by treatment with chemotherapy and infused with autologous PBMC (Cohort A) or CD25 depleted PBMC (Cohort B). Clinical observations and laboratory measurements will be monitored to evaluate safety, toxicity, immune responses, and anti-tumor effects. Additionally, the effects of treatment on tumor response will be evaluated.

Conditions

Interventions

BIOLOGICAL

PBMC re-infusion

Autologous PBMC re-infusion

BIOLOGICAL

CD25 depletion

Autologous, CD25-depleted PBMC re-infusion

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Brendan Curti, MD · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-01-31
Completion
2015-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00961376 on ClinicalTrials.gov