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High-dose ICE With Amifostine

Descriptive Information
Brief Title † High-dose ICE With Amifostine
Official Title † High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
Brief Summary The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Percentage of Participants with Grade 2 or higher renal toxicities
Secondary Outcome Measure † Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine
Condition † Bladder Cancer Brain and Central Nervous System Tumors Carcinoma of Unknown Primary Extragonadal Germ Cell Tumor Head and Neck Cancer Kidney Cancer Lung Cancer Ovarian Cancer Sarcoma Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific
Intervention † Biologicalfilgrastim
Study Arms / Comparison Groups High Dose ICF with Amifostine Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8, ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4. Patients receive amifostine IV twice a day on days -7 to -3. PBSCs are reinfused on day 0. Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover. Patients are followed monthly for the first 2 months and then for survival.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 24
Start Date † July 1998
Completion Date June 2002
Primary Completion Date November 2000
Eligibility Criteria † Eligibility Criteria: - Histologically documented malignancy - Metastatic or locally unresectable malignancy - Patient may be responding to therapy - Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols) - Relapsed germ cell carcinomas - Relapsed lymphomas (ineligible for other BMT or SCT protocols - SCLC in PR or CR - Sarcomas in or near complete remission after induction chemotherapy - Stage IIIB NSCLC responding to chemotherapy - Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary - Other tumors without curative or first line therapy (not eligible for phase II or III studies) - Aged 18 to 55 Physiologic years -- Performance status: PS 0-1 - Prior Treatment - > 1 week since surgery or RT - > 3 weeks since prior CT - Informed Consent - Required initial laboratory data: - White Cell Count Life ≥ 3000/ul - Platelet Count ≥ 100,000/ul - Creatinine ≤ 1.5 x normal - Bilirubin ≤ 1.5 x normal - No current metastases - BM Asp & Bx - Brain CAT - Creatinine Clearance ≥ 60 cc/min - SGOT
Gender All
Ages 18 Years - 55 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00003657
Organization ID 98-068
Secondary IDs †† P30CA006516, DFCI-98068, ALZA-97-038-ii, NCI-V98-1491
Responsible Party Principal Investigator
Study Sponsor † Dana-Farber Cancer Institute
Collaborators †† National Cancer Institute (NCI)
Investigators † Principal Investigator: Paul G.G. Richardson, MD, Dana-Farber Cancer Institute
Information Provided By
Verification Date January 2017
First Received Date † November 1, 1999
Last Updated Date January 19, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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