Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
- duration of neutropenia [ Time Frame: 30 days ] [ Designated as safety issue: No ]number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy
- incidence of nephrotoxicity [ Time Frame: 30 days ] [ Designated as safety issue: No ]decrease in creatinine clearance from baseline after high dose chemotherapy
- incidence of ototoxicity [ Time Frame: 30 days ] [ Designated as safety issue: No ]change in audiogram from baseline after high dose chemotherapy
| Enrollment: | 20 |
| Study Start Date: | February 1998 |
| Study Completion Date: | January 2001 |
| Primary Completion Date: | January 2001 (Final data collection date for primary outcome measure) |
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
Additional Information:
No publications provided
| Responsible Party: | James R. Mason, M.D., Scripps Health |
| ClinicalTrials.gov Identifier: | NCT00003269 History of Changes |
| Other Study ID Numbers: | CDR0000066165, SCRF-98014, ALZA-97-49-ii, NCI-V98-1396 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Scripps Health:
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Ovarian Neoplasms Lymphoma, Large-Cell, Immunoblastic Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Etoposide phosphate Cisplatin Cyclophosphamide |
ClinicalTrials.gov processed this record on June 18, 2013