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| Sponsored by: |
Ida M. and Cecil H. Green Cancer Center at Scripps Clinic |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003269 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Drug/Agent Toxicity by Tissue/Organ Lung Cancer Lymphoma Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Biological: sargramostim Drug: amifostine trihydrate Drug: cisplatin Drug: cyclophosphamide Drug: etoposide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | A Phase II, Open-Label, Trial Evaluating the Efficacy of Amifostine in Patients With Cancers Receiving Outpatient Dose-Intensive Cyclophosphamide, Etoposide, and Cisplatin (DICEP) Chemotherapy |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 1998 |
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.
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, California | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Study Chair: | James R. Mason, MD | Ida M. and Cecil H. Green Cancer Center at Scripps Clinic |
More Information
| Study ID Numbers: | CDR0000066165, SCRF-98014, ALZA-97-49-ii, NCI-V98-1396 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003269 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage I breast cancer stage II breast cancer stage IV breast cancer stage IIIA breast cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIB breast cancer stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer Waldenstrom macroglobulinemia limited stage small cell lung cancer extensive stage small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma |
|
Thoracic Neoplasms Lymphoma, Mantle-Cell Urogenital Neoplasms Mantle Cell Lymphoma Follicular Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms Ovarian Cancer Etoposide Hodgkin Disease Breast Diseases Endocrine Gland Neoplasms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Genital Neoplasms, Female |
Breast Neoplasms Endocrine System Diseases Carcinoma, Small Cell Waldenstrom Macroglobulinemia B-cell Lymphomas Lung Diseases Leukemia, T-Cell Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Lymphoma, T-Cell, Cutaneous Radiation-Protective Agents Immunologic Factors Hematologic Neoplasms Gonadal Disorders |
|
Thoracic Neoplasms Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Alkylating Agents Etoposide Lymphoma Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Ovarian Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Amifostine Skin Diseases Immune System Diseases Genital Neoplasms, Female |
