Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer
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| ClinicalTrials.gov Identifier: NCT00004036 |
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Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 13, 2004
Last Update Posted : December 19, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination chemotherapy in treating patients with advanced cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Myeloproliferative Disorders Drug/Agent Toxicity by Tissue/Organ Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Biological: sargramostim Drug: amifostine trihydrate Drug: carboplatin Drug: cyclophosphamide | Phase 1 |
OBJECTIVES: I. Determine the effects of priming on the granulocyte and thrombocyte nadirs produced by high dose cyclophosphamide and carboplatin in patients with advanced malignancies. II. Determine the effects of amifostine on the granulocyte and thrombocyte nadirs produced by this same regimen when administered with sargramostim primed progenitor cells. III. Determine the maximum tolerated dose of cyclophosphamide and carboplatin that can be administered with sargramostim primed progenitor cells.
OUTLINE: This is a dose escalation study. Patients receive intravenous amifostine over 10 minutes on day 0, followed by intravenous cyclophosphamide and carboplatin consecutively over 5-15 minutes. Sargramostim is administered subcutaneously on days -7 to -2 and again beginning on day 1 until absolute neutrophil count is appropriate. Course is repeated every 28 days until disease progression or unacceptable toxic effects are observed. Nonresponding patients discontinue treatment after 2 courses. Patients are treated for a maximum of 6 courses. Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin until the maximum tolerated dose (MTD) is determined. If dose limiting toxicity (DLT) occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD.
PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study within 1 year.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Primary Purpose: | Supportive Care |
| Official Title: | Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells |
| Study Start Date : | November 1997 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced malignancies that are sensitive to cyclophosphamide/carboplatin therapy OR refractory to standard therapy, including, but not limited to: Ovarian epithelial cancer Colorectal cancer Breast cancer Sarcoma Non-small cell lung cancer Malignant melanoma Upper gastrointestinal cancers Small cell lung cancer
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 SWOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.5 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min OR Iothalamate clearance at least 60 mL/min Cardiovascular: No significant coronary artery disease (angina of New York Heart Association class 3 or greater) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychosis
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen for advanced or recurrent malignancies (not including adjuvant chemotherapy) No prior nitrosoureas or intravenous mitomycin No concurrent cytotoxic chemotherapy Endocrine therapy: At least 1 week since prior hormone therapy and recovered Concurrent corticosteroid therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Radiotherapy allowed to no more than 1 site in the thoracic or lumbar spine or pelvis Concurrent radiotherapy to a symptomatic lesion allowed after the first course of study treatment Surgery: At least 3 weeks since prior surgery and recovered (excluding recent biopsy or placement of an intravenous access device)
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): NCT00004036
| United States, Ohio | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | George Thomas Budd, MD | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00004036 |
| Other Study ID Numbers: |
CDR0000066347 CCF-IRB-1907 IMMUNEX-001.G9701 NCI-V98-1424 |
| First Posted: | September 13, 2004 Key Record Dates |
| Last Update Posted: | December 19, 2013 |
| Last Verified: | May 2007 |
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stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent adult Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenström macroglobulinemia stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia |
unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission polycythemia vera primary myelofibrosis essential thrombocythemia untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Precancerous Conditions Myelodysplastic Syndromes Myeloproliferative Disorders Syndrome Drug-Related Side Effects and Adverse Reactions Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Chemically-Induced Disorders Cyclophosphamide Carboplatin Sargramostim |