Blood Samples From Patients With Cancer Treated on a Clinical Trial to Control Nausea and Vomiting During Donor Stem Cell Transplant

This study has been terminated.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00900068

First received: May 9, 2009

Last updated: September 21, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

September 21, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Average, median, and mode for substance P levels at different times [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00900068 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlation of substance P levels with patient response (emesis or not) [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Blood Samples From Patients With Cancer Treated on a Clinical Trial to Control Nausea and Vomiting During Donor Stem Cell Transplant

Official Title ^ICMJE

Substance P Follow-up to a Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplantation

Brief Summary

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

During the pilot study, serum samples were collected from a subgroup of patients in both the placebo and the aprepitant arms

Condition ^ICMJE

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

Intervention ^ICMJE

Other: immunoenzyme technique
Other: laboratory biomarker analysis
Other: medical chart review

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00900068

Other Study ID Numbers ^ICMJE

CDR0000617385, P30CA069533, OHSU-CPC-08055-L, OHSU-IRB 4517, MERCK-OHSU-CPC-08055-L

Has Data Monitoring Committee

Not Provided

Responsible Party

OHSU Knight Cancer Institute

Study Sponsor ^ICMJE

OHSU Knight Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Joseph Bubalo, PharmD, BCPS, BCOP

OHSU Knight Cancer Institute

Information Provided By

OHSU Knight Cancer Institute

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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