High-dose ICE With Amifostine

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00003657

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: filgrastim Drug: Amifostine Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Procedure: peripheral blood stem cell transplantation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Study Start Date :

Jul 1, 1998

Actual Primary Completion Date :

Nov 1, 2000

Actual Study Completion Date :

Jun 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: filgrastim Drug: Amifostine Other Names: Ethyol® Drug: Carboplatin Other Names: Paraplatin Drug: Etoposide Other Names: Toposar VePesid Etopophos Drug: Ifosfamide Other Names: Ifex Procedure: peripheral blood stem cell transplantation

Arm

Intervention/Treatment

Experimental: 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.

Biological: filgrastim

Drug: Amifostine

Other Names:

Ethyol®

Drug: Carboplatin

Other Names:

Paraplatin

Drug: Etoposide

Other Names:

Toposar

VePesid

Etopophos

Drug: Ifosfamide

Other Names:

Ifex

Procedure: peripheral blood stem cell transplantation

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Grade 2 or higher renal toxicities [2 Months]

Secondary Outcome Measures

Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine [2 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215