Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Astrocytoma Clinical Trial

Official title:

Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02976441
• Other study ID #: 15-x135
• Status: Withdrawn
• Phase: Early Phase 1
• First received: November 23, 2016
• Last updated: February 16, 2017
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: February 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).

• At least 18 years of age.

• Karnofsky performance status = 60%

• Normal bone marrow and organ function as defined below:

• Absolute neutrophil count = 1,500/mcl

• Platelets = 100,000/mcl

• Hematocrit = 30%

• Absolute lymphocyte count = 1000/mcl Blood transfusions are permitted to allow potential participant to meet these criteria.

• Post-operative treatment plan must include standard radiation and temozolomide.

• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed.

• Anti-VEGF therapy within 6 weeks of registration.

• A history of other malignancy = 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.

• Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study.

• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study.

• Fresh CNS bleed as evident by MRI or CT.

• Contraindicated for anticoagulation.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

• Known HIV-positivity.

Related Conditions & MeSH terms

• Astrocytoma
• Brainstem Glioma
• Ependymoma
• Glioma
• Mixed Glioma
• Oligodendroglioma
• Optic Nerve Glioma

Intervention

Radiation:
• Radiation therapy

Drug:
• Temozolomide

Procedure:
• Stem cell collection

• Stem cell infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event	The study will provide preliminary evidence of efficacy if =5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) =300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.	Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Secondary	Number of lymphocyte stem cells that can be harvested from this patient population		Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Secondary	Proportion of patients who have an increase in lymphocyte of =300 cells/mm^3 after autologous stem cell reinfusion.		4 weeks after stem cell reinfusion
Secondary	Duration of lymphocyte rise following stem cell reinfusion		Up to 6 months after stem cell reinfusion (approximately 9 months)
Secondary	Changes in lymphocyte subtypes following collection and reinfusion	Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.	Up to 6 months after stem cell reinfusion (approximately 9 months)
Secondary	Changes in series of cytokine levels following collection and reinfusion	Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.	Up to 6 months after stem cell reinfusion (approximately 9 months)
Secondary	Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events	the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.	Up to 6 months after stem cell reinfusion (approximately 9 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine