Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect
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| ClinicalTrials.gov Identifier: NCT00003425 |
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Recruitment Status :
Completed
First Posted : February 20, 2004
Last Update Posted : April 26, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Leukemia Lymphoma Neuroblastoma Ovarian Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific | Biological: filgrastim Drug: amifostine trihydrate Drug: cyclophosphamide Drug: melphalan Procedure: peripheral blood stem cell transplantation | Phase 1 Phase 2 |
OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II. Determine the complete response rate, event free survival, overall survival, and nonrelapse mortality in this patient population.
OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is given until cytapheresis is completed. Patients receive high dose melphalan according to an escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. After the MTD of high dose melphalan is determined, additional patients are treated at this dose level. Patients are followed at days 30, 100, 365, and yearly thereafter.
PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 25 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients |
| Study Start Date : | December 1997 |
| Actual Primary Completion Date : | July 2002 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Amifostine trihydrate |
Biological: filgrastim Drug: amifostine trihydrate Other Name: WR-2721 Drug: cyclophosphamide Drug: melphalan Procedure: peripheral blood stem cell transplantation |
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| Ages Eligible for Study: | 14 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Confirmed diagnosis of primary tumor and/or recurrence that has a low curative potential using other therapies, including but not limited to: Acute leukemia Myeloma Breast cancer Ovarian cancer Hodgkin's disease Non-Hodgkin's lymphoma Neuroblastoma Ewing's sarcoma In the absence of recurrence, malignancies for which an autotransplant regimen is considered a reasonable therapeutic alternative are also considered Greater than 25% of bone marrow normal cellularity and less than 10% of volume composed of tumor cells No active brain metastases or carcinomatous meningitis (controlled CNS metastases eligible)
PATIENT CHARACTERISTICS: Age: 14 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3000/mm3 Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 50% FEV1 at least 60% Other: Not pregnant or nursing Fertile patients must use effective contraception HIV, HTLV-1, and HTLV-2 negative Hepatitis B and C negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior autologous peripheral blood stem cell transplant Chemotherapy: Cumulative anthracycline or equivalent dose no greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from prior therapy No antihypertensives during and 24 hours prior to 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): NCT00003425
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Maryland | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Donna E. Reece, MD | Lucille P. Markey Cancer Center at University of Kentucky |
Publications of Results:
| Responsible Party: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00003425 History of Changes |
| Other Study ID Numbers: |
UKMC-97BMT72 CDR0000066448 ( Registry Identifier: PDQ (Physician Data Query) ) ALZA-UKMC-97BMT72 NCI-V98-1455 |
| First Posted: | February 20, 2004 Key Record Dates |
| Last Update Posted: | April 26, 2013 |
| Last Verified: | April 2013 |
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stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer recurrent adult Hodgkin lymphoma refractory multiple myeloma stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma |
stage III multiple myeloma recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia unspecified adult solid tumor, protocol specific untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission ovarian stromal cancer stage III ovarian germ cell tumor stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor acute undifferentiated leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma |
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Lymphoma Breast Neoplasms Leukemia Sarcoma Neuroblastoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Connective and Soft Tissue |
Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cyclophosphamide Melphalan Amifostine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating |