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Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016289
First received: May 6, 2001
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
 Biological: recombinant interleukin-12
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Rate of remission determined by laparoscopy or laparotomy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Tested using an exact test for a single binomial proportion

  • Toxicity graded using the NCI CTC version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Evaluated for each dose level and each course of therapy.

  • Progression-free interval [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (recombinant interleukin-12)
Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses.
 Biological: recombinant interleukin-12
Given intraperitoneally
Other Names:
  • cytotoxic lymphocyte maturation factor
  • IL-12
  • interleukin-12
  • natural killer cell stimulatory factor
  • Ro 24-7472

Detailed Description:

OBJECTIVES:

I. Determine the response rate and progression-free interval in patients with peritoneal carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma treated with intraperitoneal interleukin-12.

II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology, conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in patients treated with this regimen.

IV. Assess quality of life in patients treated with this regimen. V. Determine the pharmacology and pharmacokinetics of this drug in these patients.

VI. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.

VII. Determine whether this regimen decreases expression of vascular endothelial growth factor, fibroblast growth factor 2, and interleukin-8 as surrogate markers of angiogenesis and whether a decrease in marker expression is associated with clinical activity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses. Quality of life is assessed at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of their disease response; and then 2 weeks later. Patients are followed every 2 months for 1 year and then every 3 months for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma

    • Surgically documented disease after prior platinum-based chemotherapy with or without surgery
    • Minimal residual disease, defined as metastases less than 1 cm in largest diameter
  • No significant adhesions or symptoms of obstruction
  • No extra-abdominal or parenchymal disease
  • No more than 6 weeks since prior primary chemotherapy
  • Performance status - Zubrod 0-1
  • Absolute granulocyte count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Lymphocyte count greater than 600/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT or SGPT no greater than 2.5 times upper limit of normal
  • Albumin at least 3.0 g/dL
  • Hepatitis B and C negative
  • Creatinine no greater than 1.5 mg/dL
  • No significant cardiac disease
  • No significant pulmonary disease
  • No overt autoimmune disease
  • No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer
  • HIV negative
  • Successful placement of peritoneal catheter
  • No prior immunotherapy
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy
  • No chronic steroid therapy
  • No prior radiotherapy
  • See Disease Characteristics
  • Recovered from prior surgery
  • At least 2 weeks since prior laparoscopy
  • At least 4 weeks since prior laparotomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016289

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Renato Lenzi M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016289     History of Changes
Other Study ID Numbers: NCI-2012-02381, MDA-ID-00232, N01CM17003, CDR0000068619
Study First Received: May 6, 2001
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Interleukin-12
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013