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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00900068
• Other study ID #: CDR0000617385
• Secondary ID: P30CA069533OHSU-
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 7, 2017
• Start date: August 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Myeloproliferative Disorders
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Nausea
• Nausea and Vomiting
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Ovarian Cancer
• Plasmacytoma
• Preleukemia
• Syndrome
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Trophoblastic Neoplasms
• Vomiting

Intervention

Other:
• immunoenzyme technique

• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average, median, and mode for substance P levels at different times
Secondary	Correlation of substance P levels with patient response (emesis or not)