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Sponsors and Collaborators: |
UPMC Cancer Centers National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003439 |
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 |
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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 |
Study Start Date: | August 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213 |
Study Chair: | Robert P. Edwards, MD | UPMC Cancer Centers |
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 |
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 |
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 |
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 |