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An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer

Thank you

Trial Information

An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study


Inclusion Criteria:



- Female patients ≥ 18 years old with histologically confirmed Stage III or IV
epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in
CAN-003

- Able and willing to undergo MNC collection (if required for patients who do not have
available Cvac doses)

- Were enrolled in CAN-003 and met protocol criteria for progressive disease

- Wish to remain in the study and, in the investigator's judgment, the potential
benefit of Cvac treatment outweighs the risk

- Must be non-pregnant and, if of childbearing potential, must use adequate birth
control (hormonal or barrier method of birth control or abstinence) for the duration
of the study and for 3 months after study completion

- Able to provide written informed consent

- White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL,
hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm3

Exclusion Criteria:

- Pregnant or breastfeeding

- Other medical conditions which preclude study participation, in the opinion of the
investigator

- Receiving treatment with any other investigational product

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety will be measured through review of the number and type of adverse events associated with Cvac at all timepoints for each patient and across patients.

Outcome Time Frame:

1 Year of active dosing

Safety Issue:

No

Principal Investigator

Heidy Gray, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

CAN-003X

NCT ID:

NCT01617629

Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Cvac
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

University of Washington Medical Center Seattle, Washington  98195-6043
Scripps Cancer Center La Jolla, California  92037
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Collaborative Research Group Boynton Beach, Florida  33435
Marin Cancer Care, Inc. Greenbrae, California  94904