Blood Samples From Patients on a Clinical Trial to CINV During HSCT

NCT ID: NCT00900068

Last Updated: 2017-05-09

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

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-10-31

Brief Summary

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RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.

PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.

Detailed Description

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OBJECTIVES:

Primary

* To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

* To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.

OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.

Patients' medical records are reviewed for demographic information, past history, and course of treatment.

Conditions

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Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nausea and Vomiting Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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immunoenzyme technique

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Previously collected serum samples from patients with cancer enrolled on the placebo arm of the pilot aprepitant study

* Patients treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Joseph Bubalo

PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Bubalo, PharmD, BCPS, BCOP

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-CPC-08055-L

Identifier Type: -

Identifier Source: secondary_id

OHSU-IRB 4517

Identifier Type: -

Identifier Source: secondary_id

MERCK-OHSU-CPC-08055-L

Identifier Type: -

Identifier Source: secondary_id

CDR0000617385

Identifier Type: -

Identifier Source: org_study_id

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