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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00016289

Purpose

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer cancer or primary peritoneal cancer.

Condition	Intervention	Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer	Biological: recombinant interleukin-12	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) NSC (672423) in Patients With Peritoneal Carcinomatosis (Residual Disease <1cm) Associated With Ovarian Epithelial Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Interleukin-12

U.S. FDA Resources

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

Study Start Date:

July 2001

Detailed Description:

OBJECTIVES:

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.
Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
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.
Assess quality of life in patients treated with this regimen.
Determine the pharmacology and pharmacokinetics of this drug in these patients.
Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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 extraabdominal or parenchymal disease
No more than 6 weeks since prior primary chemotherapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute granulocyte count greater than 1,500/mm^3
Platelet count at least 100,000/mm^3
Lymphocyte count greater than 600/mm^3

Hepatic:

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

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No significant cardiac disease

Pulmonary:

No significant pulmonary disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy

Chemotherapy:

See Disease Characteristics
Recovered from prior chemotherapy
No concurrent chemotherapy

Endocrine therapy:

No chronic steroid therapy

Radiotherapy:

No prior radiotherapy

Surgery:

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, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Hermann Hospital
Houston, Texas, United States, 77030
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-1439
University of Texas Health Science Center - Houston
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Renato Lenzi, MD

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:

Lenzi R, Edwards R, June C, Seiden MV, Garcia ME, Rosenblum M, Freedman RS. Phase II study of intraperitoneal recombinant interleukin-12 (rhIL-12) in patients with peritoneal carcinomatosis (residual disease < 1 cm) associated with ovarian cancer or primary peritoneal carcinoma. J Transl Med. 2007 Dec 12;5:66.

ClinicalTrials.gov Identifier:	NCT00016289 History of Changes
Other Study ID Numbers:	CDR0000068619, MDA-ID-00232, NCI-2251
Study First Received:	May 6, 2001
Last Updated:	July 7, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal 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
Abdominal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
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 February 13, 2012