LymphopeniaPhase 1NCT02659800
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
A Phase 1 study testing Laboratory Biomarker Analysis and NT-I7 in people with Lymphopenia and Malignant Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 10 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphopenia, Malignant Glioma
- What is being tested?
- Laboratory Biomarker Analysis and NT-I7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Oct 2018to 3 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed high grade glioma by pathology (World Health Organization [WHO] grade III and IV)
- Patients' post-operative treatment must have included at least 80% of standard radiation and concomitant temozolomide; patients may not have received any other prior chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; prior Gliadel wafers are allowed; glucocorticoid therapy is allowed
- Patients must have CD4 =< 300 cells/mm^3 in the last week (7 days) of standard radiation + temozolomide treatment (58-60 Gy radiation with temozolomide 75 mg/m2 daily during radiation)
- Absolute neutrophil count >= 1,000/mcL
- Platelets >= 50,000/mcL (need to confirm before administering study drug)
- Hemoglobin >= 9 g/dL
Show all 16Show fewer
- Total bilirubin =< institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
- Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
- Patients must be able to provide written informed consent
- Women of childbearing potential must have a negative serum pregnancy test prior to study entry; women of childbearing potential and men must agree to use two birth control methods (either two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry and for the duration of study participation (through at least 90 days after the last study injection); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Dexamethasone dose must be provided for treatment group assignment:
- Group A: patients not on dexamethasone or on a dose =< 0.75 mg daily (or equivalent of an alternative corticosteroid)
- Group B: patients who require dexamethasone >= 4 mg daily (or equivalent of an alternative corticosteroid) ** Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7; corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient's group assignment
Who cannot join
- Patients receiving any other investigational agents are ineligible
- Patients with known hypersensitivity to NT-I7 or any component used in the vehicle/formulation are ineligible
- Patients with 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, are ineligible
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NT-I7
- Patients with human immunodeficiency virus (HIV) are excluded
- Patients with a known or screening-period-determined corrected QT (QTc) interval > 450 msec and patients who require a therapy with a drug known to prolong the QT/QTc interval, are ineligible
- Patients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc., are ineligible
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294-3410
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Abrams Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Washington University
St Louis, Missouri, 63110
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-related CD4 Lymphopenia After Concurrent Radiation and Temozolomide
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.
Read the detailed description
PRIMARY OBJECTIVES:
Phase I: To determine the MTD (Maximum Tolerated Dose) and select optimal biological doses (OBD) of NT-I7 in HGG patients with severe lymphopenia
Pilot Study: To test the effect of NT-I7 on CD4 counts compared to control
SECONDARY OBJECTIVES:
- To evaluate the optimal biological dose of NT-I7
- To evaluate the effect of concurrent dexamethasone
- To evaluate the duration of effect on CD4 counts (up to 6 months)
- To evaluate the total lymphocyte counts over time and serial T cell lymphocyte subtypes and the effect on T cell repertoire (up to 6 months)
- To evaluate the serial cytokine levels (up to 6 months)
- To evaluate the impact of adjuvant temozolomide on NT-I7 effects on CD4 counts
- To evaluate anti-drug antibodies
- To evaluate the pharmacokinetic profile of NT-I7 after intramuscular administration in this patient population
- To evaluate the safety and toxicity of NT-I7 in patients with high grade glioma
OUTLINE: Patients are assigned to 1 of 2 groups depending on their use of dexamethasone.
GROUP A: Patients not on dexamethasone (or equivalent of an alternative corticosteroid), or on a dose lower than a physiologic dose (=< 0.75 mg daily)
GROUP B: patients who require dexamethasone (or equivalent of an alternative corticosteroid) => 4 mg daily
Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7. Corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient's group assignment.
PHASE I TREATMENT PLAN
All patients (both Groups A and B) will be given a single dose of NT-I7 by intramuscular injection starting at 60 μg/kg, within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break. Following this period, as per standard treatment, patients will go on to receive adjuvant temozolomide on Days 1-5 of 28-day cycles for 6 cycles. There should be about six weeks between the study injection and the start of adjuvant temozolomide; thus the start of adjuvant TMZ will be approximately two weeks later than the usual start, which is 4 weeks post-end of radiation. Patients who are delayed from receiving or are not able to receive adjuvant TMZ treatment may continue on study; adjuvant TMZ treatment is not a requirement for participation.
PILOT STUDY TREATMENT PLAN
GROUP A: participants will be given either a placebo (NT-I7 diluent) or one dose of NT-I7 at the Phase I Group A OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
GROUP B: participants will be given one dose of NT-I7 at the Phase I Group B OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
After completion of study treatment, patients are followed up every 2 months for 2 years and then every 6 months thereafter.
- Conditions
- Lymphopenia, Malignant Glioma
- Being tested
- Laboratory Biomarker Analysis, NT-I7, Placebo
- Medical subject headings
- Lymphopenia, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
NT-I7Biological
Given IM
PlaceboOther
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Low Dexamethasone (LD) | Experimental | Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation
Laboratory Biomarker Analysis Correlative Studies Receives: Other: Laboratory Biomarker Analysis; Biological: NT-I7 |
| Arm B High Dexamethasone (HD) | Experimental | Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation
Laboratory Biomarker Analysis Correlative Studies Receives: Other: Laboratory Biomarker Analysis; Biological: NT-I7 |
| Arm A1 (LD) Control - Placebo | Experimental | Patients receive single dose Placebo IM (blinded). Patients also on Dexamethasone </=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot
Laboratory Biomarker Analysis Correlative Studies Receives: Other: Laboratory Biomarker Analysis; Biological: NT-I7; Other: Placebo |
| Arm A2 (LD) MTD | Experimental | Patients receive single dose MTD NT-I7 IM determined in Arm A (Blinded) . Patients also on Dexamethasone <=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot
Laboratory Biomarker Analysis Correlative Studies Receives: Other: Laboratory Biomarker Analysis; Biological: NT-I7 |
| Arm B1 HD MTD | Experimental | Patients receive single dose MTD NT-I7 IM determined in Arm B (Blinded) . Patients also on Dexamethasone >= 4mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot
Laboratory Biomarker Analysis Correlative Studies Receives: Other: Laboratory Biomarker Analysis; Biological: NT-I7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute total CD4 cell counts
The primary treatment effect is defined as an absolute increase in CD4 counts in patients treated with glycosylated recombinant human interleukin-7 compared to the control group patients without glycosylated recombinant human interleukin-7 at week 6 after radiation treatment + temozolomide treatment.
Measured: At 6 weeks (after standard radiation and temozolomide treatment completion)
Secondary outcomes (1)
Optimal dose of glycosylated recombinant human interleukin-7 determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
The optimal dose will be selected based on the highest absolute increase of CD4 counts compared to the control if toxicity profiles are similar between the two dose levels. Otherwise, safety will be the first consideration for dose selection. The results of the two concurrent dexamethasone groups will be summarized with standard descriptive statistics. The dose selection criteria will be similar to the non-dexamethasone groups with priority on safety rather than the highest absolute increase of CD4 counts.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start30 Oct 2018
- Primary completion30 Mar 2022
- Study completion3 Oct 2023
Why it stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphopeniaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose Escalation - 3 levels - Group A Dexamethasone less/equal 0.75mg/day; Group B Dexamethasone greater/equal 4mg/day. At MTD Group A - w/outDexamethasone randomized Arm 1 placebo and Arm 2 MTD; Group B MTD w/ Dexamethasone single arm
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), NeoImmuneTech
- Responsible party
- Sponsor
- Investigators
- Jian L Campian, MD, PhD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659800
- Sponsor's protocol ID
- ABTC 1403
- Other IDs
- UM1CA137443, IRB00073777
- Status last verified
- Oct 2023
- First submitted
- 15 Jan 2016
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pilot Study of the Effect of rhIL-7-hyFc (NT-I7) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-related CD4 Lymphopenia After Concurrent Radiation and Temozolomide
- ClinicalTrials.gov ID
- NCT02659800
- Acronym / sponsor ID
- ABTC 1403
- Conditions
- Lymphopenia, Malignant Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), NeoImmuneTech
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.
Detailed description
PRIMARY OBJECTIVES:
Phase I: To determine the MTD (Maximum Tolerated Dose) and select optimal biological doses (OBD) of NT-I7 in HGG patients with severe lymphopenia
Pilot Study: To test the effect of NT-I7 on CD4 counts compared to control
SECONDARY OBJECTIVES:
- To evaluate the optimal biological dose of NT-I7
- To evaluate the effect of concurrent dexamethasone
- To evaluate the duration of effect on CD4 counts (up to 6 months)
- To evaluate the total lymphocyte counts over time and serial T cell lymphocyte subtypes and the effect on T cell repertoire (up to 6 months)
- To evaluate the serial cytokine levels (up to 6 months)
- To evaluate the impact of adjuvant temozolomide on NT-I7 effects on CD4 counts
- To evaluate anti-drug antibodies
- To evaluate the pharmacokinetic profile of NT-I7 after intramuscular administration in this patient population
- To evaluate the safety and toxicity of NT-I7 in patients with high grade glioma
OUTLINE: Patients are assigned to 1 of 2 groups depending on their use of dexamethasone.
GROUP A: Patients not on dexamethasone (or equivalent of an alternative corticosteroid), or on a dose lower than a physiologic dose (=< 0.75 mg daily)
GROUP B: patients who require dexamethasone (or equivalent of an alternative corticosteroid) => 4 mg daily
Patients must have been on the group assignment dose of corticosteroids for at least 5 days prior to the dose of NT-I7. Corticosteroid dose changes prior to the start of treatment are allowed as long as they do not alter patient's group assignment.
PHASE I TREATMENT PLAN
All patients (both Groups A and B) will be given a single dose of NT-I7 by intramuscular injection starting at 60 μg/kg, within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break. Following this period, as per standard treatment, patients will go on to receive adjuvant temozolomide on Days 1-5 of 28-day cycles for 6 cycles. There should be about six weeks between the study injection and the start of adjuvant temozolomide; thus the start of adjuvant TMZ will be approximately two weeks later than the usual start, which is 4 weeks post-end of radiation. Patients who are delayed from receiving or are not able to receive adjuvant TMZ treatment may continue on study; adjuvant TMZ treatment is not a requirement for participation.
PILOT STUDY TREATMENT PLAN
GROUP A: participants will be given either a placebo (NT-I7 diluent) or one dose of NT-I7 at the Phase I Group A OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
GROUP B: participants will be given one dose of NT-I7 at the Phase I Group B OBD by intramuscular injection within one week after completing concurrent RT+TMZ and before starting adjuvant TMZ treatment, during the standard post-radiation break.
After completion of study treatment, patients are followed up every 2 months for 2 years and then every 6 months thereafter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Dose Escalation - 3 levels - Group A Dexamethasone less/equal 0.75mg/day; Group B Dexamethasone greater/equal 4mg/day. At MTD Group A - w/outDexamethasone randomized Arm 1 placebo and Arm 2 MTD; Group B MTD w/ Dexamethasone single arm
| Arm | Type | Receives |
|---|---|---|
| Arm A - Low Dexamethasone (LD) | Experimental | Other: Laboratory Biomarker Analysis, Biological: NT-I7Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies |
| Arm B High Dexamethasone (HD) | Experimental | Other: Laboratory Biomarker Analysis, Biological: NT-I7Patients receive single dose of NT-I7 IM. Treatment continues in the absence of disease progression or unacceptable toxicity. Dose Escalation Laboratory Biomarker Analysis Correlative Studies |
| Arm A1 (LD) Control - Placebo | Experimental | Other: Laboratory Biomarker Analysis, Biological: NT-I7, Other: PlaceboPatients receive single dose Placebo IM (blinded). Patients also on Dexamethasone </=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
| Arm A2 (LD) MTD | Experimental | Other: Laboratory Biomarker Analysis, Biological: NT-I7Patients receive single dose MTD NT-I7 IM determined in Arm A (Blinded) . Patients also on Dexamethasone <=0.75mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
| Arm B1 HD MTD | Experimental | Other: Laboratory Biomarker Analysis, Biological: NT-I7Patients receive single dose MTD NT-I7 IM determined in Arm B (Blinded) . Patients also on Dexamethasone >= 4mg daily Treatment continues in the absence of disease progression or unacceptable toxicity. Pilot Laboratory Biomarker Analysis Correlative Studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically confirmed high grade glioma by pathology (World Health Organization [WHO] grade III and IV)
Key exclusion criteria (7 listed)
- Patients receiving any other investigational agents are ineligible
- Patients with known hypersensitivity to NT-I7 or any component used in the vehicle/formulation are ineligible
- Patients with 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, are ineligible
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NT-I7
- Patients with human immunodeficiency virus (HIV) are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A - Low Dexamethasone (LD), Arm A1 (LD) Control - Placebo, Arm A2 (LD) MTD, Arm B High Dexamethasone (HD), Arm B1 HD MTD |
| NT-I7Given IM | Biological | Arm A - Low Dexamethasone (LD), Arm A1 (LD) Control - Placebo, Arm A2 (LD) MTD, Arm B High Dexamethasone (HD), Arm B1 HD MTD |
| PlaceboGiven IM | Other | Arm A1 (LD) Control - Placebo |
Primary outcome
Absolute total CD4 cell counts
Time frame: At 6 weeks (after standard radiation and temozolomide treatment completion)
The primary treatment effect is defined as an absolute increase in CD4 counts in patients treated with glycosylated recombinant human interleukin-7 compared to the control group patients without glycosylated recombinant human interleukin-7 at week 6 after radiation treatment + temozolomide treatment.
1 secondary outcome
Optimal dose of glycosylated recombinant human interleukin-7 determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian L Campian, MD, PhD study chair
National Cancer Institute (NCI)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Biomarker Analysis and NT-I7 in people with Lymphopenia and Malignant Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute total CD4 cell counts (time frame: At 6 weeks (after standard radiation and temozolomide treatment completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.