Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:

Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004032
• Other study ID #: NCI-2012-02255
• Secondary ID: MDA-ID-96253U01C
• Status: Completed
• Phase: Phase 1
• First received: December 10, 1999
• Last updated: January 22, 2013
• Start date: October 1997

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer

Description:

OBJECTIVES:

I. Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.

OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.

Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and

18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of ovarian epithelial carcinoma

• Previously treated with an adequate course of platinum based chemotherapy

• Evidence of intraabdominal disease

• No significant adhesions

• Performance status - Zubrod 0-2

• Lymphocyte count at least 500/mm^3

• Bilirubin no greater than 1.5 mg/dL

• SGOT less than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL

• No major disorder of the cardiovascular system

• No major disorder of the pulmonary system

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Successful placement of peritoneal catheter

• No overt autoimmune disease

• No concurrent chronic steroid therapy

• No prior radiotherapy

• Prior surgery allowed

• Recovered from prior therapy

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• ALVAC-hB7.1
Given IP
• recombinant interferon gamma
Given IP

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autologous tumor cell cytotoxicity lymphocyte (CTL)		Up to 7 years	No
Primary	Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR		Up to 7 years	No
Primary	Toxicity as assessed by NCI Common Terminology Criteria (CTC)		3 weeks	Yes