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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer  Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
For Condition: Prostate Cancer,ovarian epithelial cancer,Gastric Cancer,Colorectal Cancer,Colon Cancer,Rectal Cancer,adult primary liver cancer,Endometrial Cancer,Pancreatic Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertEdwards, Study Chair, University of Pittsburgh
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: CDR0000066467; PCI-MWH-97-039,NCI-T97-0031,PCI-98-031
Study Start Date: November 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003439
Other Endometrial Cancer Studies:
1. Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
2. Intraperitoneal and Intravenous Gemcitabine, Radiotherapy and Surgery for Advanced Cancer of the Pancreas
3. Interleukin-12 in Treating Patients With Cancer in the Abdomen
4. Vaccine Therapy with Tumor Specific Mutated P53 or Ras Peptides Alone or in Combination with Cellular Immunotherapy with Peptide Activated Lymphocytes (PAL Cells) Along with Subcutaneous IL-2
5. Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Related Studies:
Other Endometrial Cancer Clinical Trials
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Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
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