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Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003439
  Purpose

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers.


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

Study Type: Interventional
Study Design: 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):

Study Start Date: August 1998
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.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

  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% Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 9 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL ALT less than 100 U/L Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Normal electrocardiogram No recent history of cardiac ischemia Other: 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: Biologic therapy: At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2) No prior recombinant human interleukin-12 Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent systemic chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: No prior radiation therapy to the whole abdomen No concurrent radiotherapy Surgery: Not specified Other: At least 3 weeks since prior exposure to any investigational drug No concurrent investigational drug

  Contacts and Locations
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
UPMC Cancer Centers
Investigators
Study Chair: Robert P. Edwards, MD UPMC Cancer Centers
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066467, PCI-98-031, PCI-MWH-97-039, NCI-T97-0031
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003439     History of Changes
Health Authority: United States: Federal Government

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
peritoneal cavity cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Interleukin-12
Immunologic Factors
Rectal Neoplasms
Gonadal Disorders
Pancreatic Neoplasms
Endometrial Cancer
Urogenital Neoplasms
Ovarian Diseases
Bile Duct Cancer, Extrahepatic
Anal Cancer
Liver Neoplasms
Genital Diseases, Female
Stomach Neoplasms
Ovarian Cancer
Endocrine Gland Neoplasms
Ovarian Neoplasms
Adjuvants, Immunologic
Genital Neoplasms, Female
Rectal Neoplasm
Endocrine System Diseases
Ovarian Epithelial Cancer
Angiogenesis Inhibitors
Recurrence
Fallopian Tube Neoplasms
Carcinoma
Gall Bladder Cancer
Rectal Cancer
Carcinoid Tumor
Endocrinopathy

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

ClinicalTrials.gov processed this record on September 01, 2009