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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004032
First received: December 10, 1999
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Recurrent Ovarian Epithelial Cancer
Biological: ALVAC-hB7.1
Biological: recombinant interferon gamma
Other: laboratory biomarker analysis
Phase 1

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Autologous tumor cell cytotoxicity lymphocyte (CTL) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI Common Terminology Criteria (CTC) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: October 1997
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ALVAC-hB7.1, recombinant interferon gamma)
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.
Biological: ALVAC-hB7.1
Given IP
Biological: recombinant interferon gamma
Given IP
Other Names:
  • Actimmune
  • gamma interferon
  • IFN-G
Other: laboratory biomarker analysis
Correlative studies

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004032

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Ralph Freedman M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004032     History of Changes
Other Study ID Numbers: NCI-2012-02255, MDA-ID-96253, U01CA062461, CDR0000065850
Study First Received: December 10, 1999
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014