Intensive Combo Chemo With Autologous BM Rescue for Metas... | NCT00584766

Studies
Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

NCT00584766

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

21Actual

Phase

Phase 2

Conditions

Metastatic Breast Cancer

Interventions

High-dose chemotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OU 8701

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1987

Primary Completion Date

May 2002Actual

Completion Date

May 2002Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Jan 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2015

Last Update Posted Date

May 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Procedure: High-dose chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-dose chemotherapy	Procedure	Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of maximal response; time to initial disease progression; and overall survival		undetermined

Secondary Outcomes

Measure	Description	Time Frame
to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer		undetermined

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast carcinoma at first clinical evidence of metastatic disease
must have measurable disease by physical exam, x-ray, or scan
Age < or equal to 55
performance status 0-2

Exclusion Criteria:

can't have had more than one prior chemotherapy regimen
can't have had concurrent hormonal therapy
no brain metastases
no previous pelvic radiation
no history of another malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Selby, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided