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

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00900068
Collaborator
National Cancer Institute (NCI) (NIH)
9
1
14
0.6

Study Details

Study Description

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 Design

Study Type:
Observational
Actual Enrollment :
9 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Average, median, and mode for substance P levels at different times []

Secondary Outcome Measures

  1. Correlation of substance P levels with patient response (emesis or not) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 OHSU Knight Cancer Institute Portland Oregon United States 97239-3098

Sponsors and Collaborators

  • OHSU Knight Cancer Institute
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joseph Bubalo, PharmD, BCPS, BCOP, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joseph Bubalo, PharmD, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00900068
Other Study ID Numbers:
  • CDR0000617385
  • P30CA069533
  • OHSU-CPC-08055-L
  • OHSU-IRB 4517
  • MERCK-OHSU-CPC-08055-L
First Posted:
May 12, 2009
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017
Keywords provided by Joseph Bubalo, PharmD, OHSU Knight Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2017