High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Biological: filgrastim; Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: ifosfamide; Drug: mesna; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation

• Registration Number: NCT00002854
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
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Detailed Description

OBJECTIVES:

* Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1994-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential high dose chemotherapy	paclitaxel	-
Sequential high dose chemotherapy	cisplatin	-
Sequential high dose chemotherapy	peripheral blood stem cell transplantation	-
Sequential high dose chemotherapy	etoposide	-
Sequential high dose chemotherapy	filgrastim	-
Sequential high dose chemotherapy	cyclophosphamide	-
Sequential high dose chemotherapy	carboplatin	-
Sequential high dose chemotherapy	ifosfamide	-
Sequential high dose chemotherapy	mesna	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of two cycles of high dose chemothearpy and stem cell reinfusion	30 days from start of course II of treatment
Feasibility of two cycles of high dose chemotherapy with stem cell reinfusion	30 days from start of course II of treatment
Toxicity of two cycles of high dose chemothearpy and stem cell reinfusion	30 days from start of course II of treatment	Toxicity graded according to the NCI Common Toxicity Criteria and amended for subjects undergoing transplantation

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States