Ovarian Cancer Vaccine for Patients in Remission

Epithelial Ovarian Cancer Clinical Trial

Official title:

A Randomized, Open-Label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac) for Epithelial Ovarian Cancer Patients in First or Second Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068509
• Other study ID #: CAN-003
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2010
• Last updated: May 26, 2015
• Start date: June 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: Prima BioMed Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac)in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.

Description:

STUDY OBJECTIVES:

The purpose of this trial is to determine the safety and efficacy of Cvac compared with Observational Standard of Care in ovarian cancer patients who are in remission after first or second-line therapy.

Primary Objectives:

• To confirm the safety of administering Cvac in this population.

• To determine the effects of Cvac on progression-free survival (PFS).

Secondary Objectives:

• To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.

• Evaluation of host immunologic response to Cvac administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female subjects = 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).

• CA-125 = upper limit of normal with a prior history of an elevated CA-125.

• Able and willing to undergo MNC collection.

• Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.

• No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.

• No prior treatment with an investigational product within 30 days of enrollment.

• Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.

• Serum creatinine = 2 mg/dL.

• Serum aspartate aminotransferase or serum alanine aminotransferase = 2.5x the upper limit of normal or serum total bilirubin = 1.5x the upper limit of normal.

• White blood cell count = 3.0 K/µL; absolute neutrophil count = 1.5K/µL; hemoglobin = 9.0 g/dL, and platelets = 100,000/mm3. (These CBC results are required for enrollment. It should be noted that complete blood count results, including monocyte count = 0.2 × 10^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for CVac™ manufacture.)

• Life expectancy of at least 12 months.

• Eastern Cooperative Oncology Group Performance Status of 0-1.

• All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade = 1.

• 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.

Exclusion Criteria:

• Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.

• Ovarian germ cell, sarcoma, or mixed Mullerian tumors.

• Prior cancer vaccine or cellular therapy.

• Active uncontrolled infections or any organ system toxicity = Grade 2 by Common Terminology Criteria for Adverse Events criteria.

• Inability to provide informed consent or to comply with study-related procedures

• Concurrent systemic treatment with steroids or other immunosuppressive agents.

• Diagnosed immunodeficiency and/or autoimmune disorders.

• Myocardial infarction in the past 6 months and/or clinically significant heart disease.

• Infection with human immunodeficient virus (HIV), Hepatitis B or C virus.

• Pregnant or breastfeeding.

• Evidence or history of central nervous system metastases.

• Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.

• Hematopoietic growth factors administered within 14 days of enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• MUC1 Dendritic Cell Vaccine (Cvac)
Patients will receive vaccinations every four weeks for 24 weeks followed by injections every eight weeks for an additional 24 weeks.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Peter MacCallum Cancer Cetnre	East Melbourne	Victoria
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Austin Health Cancer Centre	Heidelberg	Victoria
Australia	Gold Coast Hospital	Southport	Queensland
United States	Northside Hospital	Atlanta	Georgia
United States	Collaborative Research Group	Boca Raton	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Marin Cancer Care, Inc.	Greenbrae	California
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Scripps Cancer Center	La Jolla	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	New York Downtown Hospital	New York	New York
United States	Stanford University School of Medicine	Palo Alto	California
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Prima BioMed Ltd

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (15)

Apostolopoulos V, Karanikas V, Haurum JS, McKenzie IF. Induction of HLA-A2-restricted CTLs to the mucin 1 human breast cancer antigen. J Immunol. 1997 Dec 1;159(11):5211-8. — View Citation

Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. Review. — View Citation

Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. Review. — View Citation

Austin Research Institute. SOP #8116 Stages 3-4. Procedures for the ex vivo Generation of MF-P Vaccine Pulsed SC, Phase I Clinical Trial. V006, 10 June 2003.

Austin Research Institute. SOP #811609. Leukapheresis for ex vivo Culture or Human Dendritic Cells for Immunotherapy. V004, 9 January 2004.

Clinical Study Report: A Phase II Trial of Cellular Immunotherapy with M-FP Cancer Vaccine in Subjects with Epithelial Ovarian Cancer, 2007 (with permission from Martin Rogers of Prima Biomed).

Desai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).

Grossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6. — View Citation

Immunotherapy for Prostate AdenoCarcinoma Treatment (IMPACT) Phase 3 study summary of sipuleucel-T in castrate-resistant prostate cancer: http://www.bio-medicine.org/medicine-technology-1/

Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. — View Citation

Liu PY, Alberts DS, Monk BJ, Brady M, Moon J, Markman M. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol. 2007 Aug 20;25(24):3615-20. — View Citation

Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. — View Citation

Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. Review. — View Citation

Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.

Rustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of Cvac administration in this population.		2 years	No
Primary	Progression Free Survival		2 years	No
Secondary	Overall survival	For eligible patients that have completed or terminated the study, the collection of Overall Survival data will continue through October 2015.	2 years	No
Secondary	Evaluation of immunologic parameters subsequent to Cvac administration.		2 years	No

External Links

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