Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
1998-07-31
2002-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
filgrastim
Amifostine
Carboplatin
Etoposide
Ifosfamide
peripheral blood stem cell transplantation
Interventions
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filgrastim
Amifostine
Carboplatin
Etoposide
Ifosfamide
peripheral blood stem cell transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Paul G. Richardson, MD
Richardson, Paul MD
Principal Investigators
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Paul G.G. Richardson, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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DFCI-98068
Identifier Type: -
Identifier Source: secondary_id
ALZA-97-038-ii
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1491
Identifier Type: -
Identifier Source: secondary_id
98-068
Identifier Type: -
Identifier Source: org_study_id
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