Clinical trial NCT00003657: High-dose ICE With Amifostine
Official title: High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 \< 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

Primary outcomes:
measure: Percentage of Participants with Grade 2 or higher renal toxicities
timeFrame: 2 Months
Secondary outcomes:
measure: Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine
timeFrame: 2 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Paul G.G. Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.