Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00003269 |
|
Recruitment Status :
Completed
First Posted : May 24, 2004
Last Update Posted : January 10, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | February 1998 |
| Actual Primary Completion Date : | January 2001 |
| Actual Study Completion Date : | January 2001 |
- duration of neutropenia [ Time Frame: 30 days ]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 ]decrease in creatinine clearance from baseline after high dose chemotherapy
- incidence of ototoxicity [ Time Frame: 30 days ]change in audiogram from baseline after high dose chemotherapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003269
| 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 |
| Responsible Party: | James R. Mason, M.D., Scripps Health |
| ClinicalTrials.gov Identifier: | NCT00003269 |
| Other Study ID Numbers: |
CDR0000066165 SCRF-98014 ( Other Identifier: Scripps Health ) ALZA-97-49-ii ( Other Identifier: Alza Corporation ) NCI-V98-1396 ( Other Identifier: NCI ) |
| First Posted: | May 24, 2004 Key Record Dates |
| Last Update Posted: | January 10, 2011 |
| Last Verified: | January 2011 |
|
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 |
|
Lymphoma Breast Neoplasms Lung Neoplasms Drug-Related Side Effects and Adverse Reactions Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
Lung Diseases Respiratory Tract Diseases Chemically-Induced Disorders Cyclophosphamide Etoposide Sargramostim Amifostine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |