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

Primary Purpose

Astrocytoma, Brainstem Glioma, Ependymoma

Status

Withdrawn

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Radiation therapy

Temozolomide

Stem cell collection

Stem cell infusion

About this trial

This is an interventional treatment trial for Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Arm Description

Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide Focal radiation therapy: standard of care dose daily for approximately 6 weeks Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of lymphocyte stem cells that can be harvested from this patient population

Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.

Duration of lymphocyte rise following stem cell reinfusion

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.

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.

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.

Full Information

NCT ID

NCT02976441

First Posted

November 23, 2016

Last Updated

February 16, 2017

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02976441

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Physician decided not to go through with study

Study Start Date

January 2017 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodar®

Intervention Type

Procedure

Intervention Name(s)

Stem cell collection

Intervention Type

Procedure

Intervention Name(s)

Stem cell infusion

Primary Outcome Measure Information:

Title

Description

Time Frame

Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)

Secondary Outcome Measure Information:

Title

Number of lymphocyte stem cells that can be harvested from this patient population

Time Frame

Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)

Title

Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.

Time Frame

4 weeks after stem cell reinfusion

Title

Duration of lymphocyte rise following stem cell reinfusion

Time Frame

Up to 6 months after stem cell reinfusion (approximately 9 months)

Title

Changes in lymphocyte subtypes following collection and reinfusion

Description

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.

Time Frame

Up to 6 months after stem cell reinfusion (approximately 9 months)

Title

Changes in series of cytokine levels following collection and reinfusion

Description

Time Frame

Up to 6 months after stem cell reinfusion (approximately 9 months)

Title

Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events

Description

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.

Time Frame

Up to 6 months after stem cell reinfusion (approximately 9 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Li Campian, M.D., Ph.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.siteman.wustl.edu

Description

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

Learn more about this trial

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

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