High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

NCT ID: NCT00584428

Last Updated: 2019-11-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-06-30

Study Completion Date

2002-03-31

Brief Summary

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To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

Detailed Description

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There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

High-Dose Chemo with Autologous BMT

Intervention Type PROCEDURE

Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70

Interventions

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High-Dose Chemo with Autologous BMT

Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of breast cancer
* Age 18-70
* Breast cancer at first clinical evidence of metastatic disease
* Must have objectively measurable or evaluable disease or be in complete remission

Exclusion Criteria

* Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
* CNS involvement
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stephenson Cancer Center

UNKNOWN

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Selby, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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OU 9206

Identifier Type: -

Identifier Source: secondary_id

OU 9206

Identifier Type: -

Identifier Source: org_study_id

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