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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 certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer conditions. Clinical Trials Search.org is a website committed 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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 undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid 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. Subjects frequently get 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, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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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
Other Ovarian Epithelial Cancer Studies:
1. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
2. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
3. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
4. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
5. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
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Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
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