High-dose ICE With Amifostine

Lung Cancer Clinical Trial

Official title:

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003657
• Other study ID #: 98-068
• Secondary ID: P30CA006516DFCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 19, 2017
• Start date: July 1998
• Est. completion date: June 2002

Study information

• Verified date: January 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2002
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• filgrastim

Drug:
• Amifostine

• Carboplatin

• Etoposide

• Ifosfamide

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Grade 2 or higher renal toxicities		2 Months
Secondary	Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine		2 Months