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Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003439
First received: November 1, 1999
Last updated: February 6, 2013
Last verified: April 2007
  Purpose

Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells.


Condition Intervention Phase
Cancer
Biological: recombinant interleukin-12
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis

Resource links provided by NLM:


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

Enrollment: 36
Study Start Date: August 1998
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease, patient may receive up to 9 additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity.
Biological: recombinant interleukin-12

Detailed Description:

OBJECTIVES:

I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis.

II. Determine the immunopharmacologic profile of rhIL-12 in this patient population.

III. Evaluate the biologic response in selected patients to rhIL-12 administered through intraperitoneal infusions.

OUTLINE: This is a dose escalation, multicenter study.

Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease, patient may receive up to 9 additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity.

All patients are followed for survival.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed intraabdominal cancer
  • Diffuse abdominal carcinomatosis Chemotherapy refractory advanced stage ovarian cancer
  • Measurable disease
  • Residual, recurrent, or metastatic disease beyond the scope of standard curative therapy
  • Extension of disease to sites distant to the peritoneal cavity allowed Retroperitoneal lymphadenopathy allowed as long as there is evaluable intraabdominal disease
  • No history of progressive brain metastases

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: Karnofsky 70-100%
  • Hemoglobin greater than 9 g/dL
  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3
  • Bilirubin less than 2.0 mg/dL
  • ALT less than 100 U/L
  • Creatinine clearance greater than 60 mL/min
  • Normal electrocardiogram
  • No recent history of cardiac ischemia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hepatitis B negative
  • No evidence of clinical immunodeficiency syndromes or immunodeficiency associated diseases
  • No history of autoimmune disease
  • No concurrent major illness
  • No serious infection requiring intravenous antibiotics
  • No active peptic ulcer disease
  • Must have free flow of fluid into the peritoneal space
  • No leakage from the catheter exit site

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2)
  • No prior recombinant human interleukin-12
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent systemic chemotherapy
  • No concurrent systemic corticosteroids
  • No prior radiation therapy to the whole abdomen
  • No concurrent radiotherapy
  • At least 3 weeks since prior exposure to any investigational drug
  • No concurrent investigational drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003439

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Study Chair: Robert P. Edwards, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003439     History of Changes
Other Study ID Numbers: NCI-2012-02272, PCI-98-031, PCI-MWH-97-039, NCI-T97-0031, CDR0000066467
Study First Received: November 1, 1999
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV gastric cancer
recurrent gastric cancer
recurrent pancreatic cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage IV anal cancer
recurrent anal cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
advanced adult primary liver cancer
recurrent adult primary liver cancer
stage IV endometrial carcinoma
recurrent endometrial carcinoma
small intestine adenocarcinoma
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
stage IV prostate cancer
recurrent prostate cancer
fallopian tube cancer
primary peritoneal cavity cancer
stage IV pancreatic cancer

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

ClinicalTrials.gov processed this record on November 27, 2014