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DCVax-L Vaccination With CD3/CD28 Costimulated Autologous T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer

NCT00603460 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-02

No results posted yet for this study

Summary

Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous vaccine with DC loaded in vitro with autologous tumor lysate.

Phase I Subjects enrolled in this study will receive leukapheresis; followed by cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a single DCVax-L vaccination, to establish feasibility and safety of this approach.

Primary Objectives of Phase I

To determine the feasibility and safety of administering vaccine-primed, ex vivo CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine.

Phase II

Twenty-two additional subjects will be randomized to receive either:

* ARM-IIA: maintenance DCVax-L vaccination, in combination with oral metronomic cyclophosphamide, or
* ARM-IIB: leukapheresis, followed by cyclophosphamide/fludarabine-induced lymphodepletion, followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells, followed by maintenance DCVax-L vaccination, plus oral metronomic cyclophosphamide.

Primary Objective of Phase II

To assess the distribution of progression-free survival at 6 months for patients treated with maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L boost vaccination and metronomic oral cyclophosphamide.

Conditions

Interventions

BIOLOGICAL

DCVax-L and T Cells

Arm A * Optional DCVax-L prior to chemotherapy * Apheresis * Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide) * Infusion of activated T cells * DCVax-L vaccine * End of study visit Arm B * Optional DCVax-L prior to chemotherapy * Apheresis * Chemotherapy for 3 days (IV fludarabine/cyclosphosphamide) * Infusion of activated T cells * DCVax-L vaccine * Oral cyclophosphamide (one week on/one week off) for a total for a total of 6 weeks * End of study visit

Sponsors & Collaborators

Principal Investigators

  • George Coukos, M.D., Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Diseases
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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 NCT00603460 on ClinicalTrials.gov