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Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer Clinical research trials and Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer  Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
For Condition: Lymphoma,Testicular Cancer,Breast Cancer,Leukemia,Multiple Myeloma,kidney tumor,ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Midwestern Regional Medical Center ,
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation with biological therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim, interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer.
Details: OBJECTIVES: I. Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer. II. Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients. III. Determine the cellular response to this regimen in these patients. IV. Assess progression free and overall survival rates in these patients. PROTOCOL OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa. Beginning 14 days after the autologous stem cell transplant, patients receive daily subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous interleukin-2 on days 3-7, followed by 1 week of rest. Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest. Treatment is repeated for four courses. Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose escalation occurs in courses 2-4, in the absence of dose limiting toxicity. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR): Metastatic breast cancer; Multiple myeloma; Hodgkin's disease; Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma; Acute myelogenous leukemia beyond first remission; Acute lymphoblastic leukemia beyond first remission; Ovarian cancer; Refractory malignancy and measurable or evaluable disease (at time of ASCR) - Hormone receptor status: Not specified [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: Not specified - Menopausal status: Not specified - Performance status: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnastasiosRaptis, Study Chair, Midwestern Regional Medical Center
Midwestern Regional Medical Center
Zion, Illinois, 60099
United States
Additional Information:
Study ID Numbers: CDR0000066418; MRMC-CTCA-9801,NCI-V98-1449
Study Start Date: April 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003408
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Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
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