High-dose ICE With Amifostine

NCT00003657 | Completed Phase 2 DMC

• 5 other identifiers: 98-068P30CA006516DFCI-98068ALZA-97-038-iiNCI-V98-1491
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Grade 2 or higher renal toxicities

  2 Months

Secondary Outcomes (1)

• Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine

  2 Months

Study Arms (1)

High Dose ICF with Amifostine

EXPERIMENTAL

* 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; Drug: Amifostine; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

High Dose ICF with Amifostine

Amifostine DRUG

Also known as: Ethyol®

High Dose ICF with Amifostine

Carboplatin DRUG

Also known as: Paraplatin

High Dose ICF with Amifostine

Etoposide DRUG

Also known as: Toposar, VePesid, Etopophos

High Dose ICF with Amifostine

Ifosfamide DRUG

Also known as: Ifex

High Dose ICF with Amifostine

peripheral blood stem cell transplantation PROCEDURE

High Dose ICF with Amifostine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Elias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Central Nervous System Neoplasms; Neoplasms, Unknown Primary; Head and Neck Neoplasms; Kidney Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Sarcoma; Testicular Germ Cell Tumor; Osteosarcoma; Carcinoma, Non-Small-Cell Lung; Chondrosarcoma; Carcinoma, Ovarian Epithelial; Small Cell Lung Carcinoma; Testicular Neoplasms; AIDS-related Kaposi sarcoma; Sarcoma, Kaposi; Squamous Cell Carcinoma of Head and Neck; Esthesioneuroblastoma, Olfactory; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Filgrastim; Amifostine; Carboplatin; Etoposide; etoposide phosphate; Ifosfamide; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Nervous System Neoplasms; Nervous System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue; Carcinoma, Squamous Cell; Neuroblastoma; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Paul G.G. Richardson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Richardson, Paul MD

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 31, 2004
• Study Start: July 1, 1998
• Primary Completion: November 1, 2000
• Study Completion: June 1, 2002
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)