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Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical research trials and Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer. Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer  Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
For Condition: recurrent ovarian epithelial cancer,peritoneal cavity cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RenatoLenzi, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Ralph Freedman 713-792-2764
University of Texas- Houston Medical School *Recruiting*
Houston, Texas, 77030
United States
Recruiting Philip Johnson 713-792-5000
Hermann Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Pablo Okhuysen 713-500-6736
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Michael Seiden 617-724-3123
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Stephen Rubin 215-349-8382
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Ursula Matulonis 617-632-2334
James Graham Brown Cancer Center at University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Robert Edwards 502-629-2448
Additional Information:
Study ID Numbers: CDR0000068619; NCI-2251,MDA-ID-00232
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016289
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Tumor Vaccine and Interferon gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
2. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
3. Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
4. UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
5. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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