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Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
This study has been completed.

First Received on December 10, 1999.   Last Updated on February 6, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004032
  Purpose

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
 Biological: ALVAC-hB7.1
Biological: recombinant interferon gamma
 Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-hB7.1 Plus IP rIFN-Gamma for Patients With Ovarian Cancer. A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Interferon gamma-1b Gamma Rays Interferons
U.S. FDA Resources

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

Study Start Date: October 1997
Detailed Description:

OBJECTIVES:

  • 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

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian epithelial carcinoma
  • Previously treated with an adequate course of platinum based chemotherapy
  • Evidence of intraabdominal disease
  • No significant adhesions

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Lymphocyte count at least 500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT less than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No major disorder of the cardiovascular system

Pulmonary:

  • No major disorder of the pulmonary system

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Successful placement of peritoneal catheter
  • No overt autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No concurrent chronic steroid therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Prior surgery allowed

Other:

  • Recovered from prior therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004032

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Ralph S. Freedman, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Freedman RS, Platsoucas CD, Scholm J, et al.: Infection of fresh epithelial ovarian carcinoma (EOC) cells with a canarypox construct ALVAC-hB7.1 after in vitro treatment with rIFN-gamma and early clincial results. [Abstract] Proc Am Assoc Cancer Res 40: A3792, 1999.

ClinicalTrials.gov Identifier: NCT00004032     History of Changes
Other Study ID Numbers: CDR0000065850, MDA-ID-96253, NCI-T96-0106
Study First Received: December 10, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer

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

ClinicalTrials.gov processed this record on February 09, 2012



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