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Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors Clinical research trials and Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
For Condition: Breast Cancer,Lung Cancer,Lymphoma,Leukemia,Ovarian Cancer
Status: No longer recruiting
Sponsor(s): Scripps Clinic ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.
Details: OBJECTIVES: I. Evaluate the efficacy of amifostine in enhancing hematopoietic recovery following cyclophosphamide, etoposide, and cisplatin therapy in patients with hematologic malignancies and adult solid tumors. PROTOCOL OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2. Cyclophosphamide is administered over 3 hours on days 0 and 1, intravenous etoposide over 4 hours on days 0, 1, and 2, and cisplatin over 4 hours on days 0, 1, and 2. All patients receive sargramostim (GM-CSF) beginning on day 4. Patients receive a maximum of 2 courses of treatment (with 35-42 days between chemotherapy courses). Patients are followed for 1-5 months after treatment. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed hematologic malignancies and adult solid tumors, including: Non-Hodgkin's lymphoma; Lung cancer; Hodgkin's disease; Ovarian cancer; Breast cancer - No refractory disease (less than partial response to induction chemotherapy) - No CNS metastases - No unilateral bone marrow biopsy within 6 months of study showing at least 20% involvement by fibrosis tumors - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior myeloid growth factor - Chemotherapy: At least 4 weeks since prior chemotherapy; No more than 1 prior chemotherapy regimen (excluding adjuvant chemotherapy) - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since pelvic, para-aortic, inverted Y, cranial, spinal, or mediastinal radiation - Surgery: At least 2 weeks since major surgery - Other: No antihypertensive medication within 24 hours of amifostine administration --Patient Characteristics-- - Age: 18 to 70 - Menopausal status: Not specified - Performance Status: ECOG 0-2 - Life expectancy: At least 16 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT or SGPT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 2 mg/dL - Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No underlying medical or psychiatric conditions; No concurrent active infection; No prior malignancies except nonmelanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesMason, Study Chair, Scripps Clinic
Scripps Clinic
La Jolla, California, 92037
United States
Additional Information:
Study ID Numbers: CDR0000066165; SCRF-98014,NCI-V98-1396,ALZA-97-49-ii
Study Start Date: February 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003269
Other Ovarian Cancer Studies:
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2. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
3. XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
4. Treatment for Chronic Pain in Patients With Advanced Cancer
5. Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
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Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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