High-dose ICE With Amifostine

Study Overview
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Brief Summary
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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.

Official Title
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High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Conditions
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Lung Cancer, Bladder Cancer, Brain and Central Nervous System Tumors, Carcinoma of Unknown Primary, Extragonadal Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: filgrastim
* Drug: Amifostine
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Ifosfamide
* Procedure: peripheral blood stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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 < 2.5 x normal No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, or congestive heart failure Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled Pregnancy Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose ICF with Amifostine<br>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. | Biological: filgrastim<br> <br> Drug: Amifostine<br> <br> * Other names: Ethyol®;Drug: Carboplatin<br> <br> * Other names: Paraplatin;Drug: Etoposide<br> <br> * Other names: Etopophos;Drug: Ifosfamide<br> <br> * Other names: Ifex;Procedure: peripheral blood stem cell transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Grade 2 or higher renal toxicities |  | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine |  | 2 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic osteosarcoma, recurrent non-small cell lung cancer, chondrosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent osteosarcoma, stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IIIB non-small cell lung cancer, unspecified adult solid tumor, protocol specific, classic Kaposi sarcoma, immunosuppressive treatment related Kaposi sarcoma, AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, ovarian stromal cancer, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, extragonadal germ cell tumor, newly diagnosed carcinoma of unknown primary, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, recurrent carcinoma of unknown primary, ovarian sarcoma, adult central nervous system germ cell tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, clear cell sarcoma of the kidney, stage IV adult soft tissue sarcoma