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Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Clinical research trials and Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors  Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
For Condition: Breast Cancer,Leukemia,kidney tumor,Multiple Myeloma,ovarian epithelial cancer,Testicular Cancer,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Indiana University Cancer Center
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 cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating patients who have hematologic cancer or solid tumor.
Details: OBJECTIVES: I. Assess the safety and maximum tolerated dose of interleukin-12 (IL-12) in patients with hematologic malignancies or solid tumors who have undergone high-dose chemotherapy and autologous stem cell transplantation. II. Evaluate the hematologic and immunologic effects of IL-12 in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV as a single test dose followed by 2 weeks of rest. Patients then receive IL-12 IV daily for 5 days followed by 16 days rest for up to 6 treatment courses. Cohorts of 3-5 patients receive escalating doses of IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 of 5 patients experience dose-limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 17-27 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 proven hematologic malignancies or solid tumors; Undergone high-dose chemotherapy or chemoradiotherapy with autologous bone marrow and/or peripheral blood stem cell transplantation; Confirmation of complete remission is required for acute leukemia - No significant CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No concurrent biologic therapy - Chemotherapy: See Disease Characteristics - Endocrine therapy: No concurrent systemic corticosteroids (other than replacement doses); At least 3 weeks since prior corticosteroids - Radiotherapy: See Disease Characteristics - Surgery: Not specified - Other: No concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed); Platelet count at least 50,000/mm3 (transfusion independent); No clinically significant coagulopathy (unless due to cancer and resolved) - Hepatic: Bilirubin no greater than 2 mg/dL; SGOT no greater than 2 times upper limit of normal; No chronic or acute hepatitis; Hepatitis B surface antigen negative - Renal: Creatinine no greater than 2 mg/dL; No symptomatic hypercalcemia AND Calcium less than 12 mg/dL - Cardiovascular: No uncontrolled angina; No arrhythmias requiring drug or device therapy; No symptomatic congestive heart failure - Pulmonary: No clinically significant pulmonary dysfunction - Metabolic: No uncontrolled diabetes mellitus; No untreated hyper or hypothyroidism; No Cushing's disease - Gastrointestinal: No clinically significant gastrointestinal hemorrhages; No uncontrolled peptic ulcer disease; No history of inflammatory bowel disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No serious infection requiring IV antibiotics; No psychosis; No clinically significant ascites or pleural effusions; No clinically significant autoimmune disease; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelRobertson, Study Chair, Indiana University Cancer Center
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Additional Information:
Study ID Numbers: CDR0000065848; IUMC-9708-05,NCI-T97-0027
Study Start Date: October 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003107
Other Lymphoma Studies:
1. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
2. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
3. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
4. Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
5. Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
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Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
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