Metastatic Renal Cell CarcinomaPhase 1/2NCT01550367
Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)
A Phase 1/2 study testing Hydroxychloroquine and IL-2 in people with Metastatic Renal Cell Carcinoma, run by Leonard Appleman at 7 sites in United States.
Trial summary
The main goal of the research study is to determine whether treating renal cell cancer patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of kidney cancer that has spread to other parts of the body, can make the cancer easier to kill and eliminate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Hydroxychloroquine and IL-2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2012to Feb 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed metastatic renal cell carcinoma with predominantly clear cell histology.
- Have measurable disease by RECIST 1.1 criteria. For example, this would include tumor in the lung, liver, and retroperitoneum. Bone disease is difficult to follow and quantify and as a sole site would not be acceptable.
- Patients must be at least 4 weeks from radiation or surgery and recovered from all ill effects.
- Age ≥18 years.
- Karnofsky Performance Status ≥80%.
- Adequate end organ function:
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- Hematologic: ANC ≥ 1000cells/uL, platelets ≥ 100,000/uL, hemoglobin ≥ 9g/dl (pre transfusion values used for prognostic factor, can be transfused or use recombinant erythropoietin growth factors but must not have active bleeding).
- Liver: AST ≤ 2 x ULN (upper limit of normal), serum total bilirubin ≤ 2 x ULN (except for patients with Gilbert's Syndrome).
- Renal: serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60ml/min using Cockcroft-Gault estimation using the formula per protocol.
- Pulmonary: FEV1 ≥ 2.0 liters or ≥ 75% of predicted for height and age. (PFTs are required for patients over 50 or with significant pulmonary or smoking history defined as >20 pack years or history of COPD/emphysema).
- Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than one year prior to entry, serious cardiac arrhythmias, or unstable angina. Patients who are over 40 or have had previous cardiac disease will be required to have a negative or low probability cardiac stress test for cardiac ischemia.
- Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
- Appropriate contraception in both genders.
- The patient must be competent and have signed informed consent.
- CNS: No history of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases.
Who cannot join
- Patients who have previously received IL-2 are NOT eligible. Patients on HCQ in neoadjuvant protocols or in the past for clinical indications ARE eligible, as are patients who have previously received CTLA-4 and/or PD-1/PD-L1 antibodies.
- Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence or breast CIS.
- In patients with a prior history of invasive malignancy, less than five years in complete remission.
- Positive serology for HIV, hepatitis B or hepatitis C.
- Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen.
- Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 2 weeks must have passed since the last dose).
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- History of inflammatory bowel disease or other serious autoimmune disease. (Not including thyroiditis and rheumatoid arthritis). Patients already on hydroxychloroquine for such disorders are not eligible.
- Patients with organ allografts.
- Uncontrolled hypertension (BP >150/100 mmHg).
- Proteinuria dipstick > 3+ or ≥ 2gm/24 hours.
- Urine protein:creatinine ratio ≥ 1.0 at screening.
- Major surgery, open biopsy, significant traumatic injury within 28 days of starting treatment or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to starting treatment. Central venous catheter placements are permitted.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to starting treatment.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of tumor-related or other serious hemorrhage, bleeding diathesis, or underlying coagulopathy.
- History of deep venous thrombosis, clinically significant peripheral vascular disease, or other thrombotic event.
- Inability to comply with study and/or follow-up procedures.
- Individuals with known history of glucose 6 phosphate deficiency are excluded from the trial (possible issue with HCQ tolerance).
- Patients with previously documented macular degeneration or diabetic retinopathy are excluded from the trial.
- Baseline EKG with QTc > 470 msec (including subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Dartmouth-Hitchcock Medical Center
Hanover, New Hampshire, 03755
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Loyola University Chicago
Maywood, Illinois, 60153
University of Pittsburgh Cancer Institute / UPMC CancerCenter
Pittsburgh, Pennsylvania, 15232
Providence Health & Services
Portland, Oregon, 97213
About this study
Official title: Inhibiting the Systemic Autophagic Syndrome - A Phase I/II Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC). A Cytokine Working Group (CWG) Study
The main goal of the research study is to determine whether treating renal cell cancer patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of kidney cancer that has spread to other parts of the body, can make the cancer easier to kill and eliminate. Another goal is to see how the study drug affects the body's immune cells which fight cancer cells.
Read the detailed description
The rationale for combining the high dose bolus aldesleukin with hydroxychloroquine includes potential positive interactions on the immune regulatory side, non-overlapping toxicities, and potential for prolongation and increased number of responses based on murine studies conducted at the University of Pittsburgh. This study is a multi-center phase II study designed to estimate the efficacy of combination therapy of standard high dose bolus IL-2 and various doses of hydroxychloroquine therapy in metastatic RCC patients.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Hydroxychloroquine, IL-2
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Continuous oral administration (at 600 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2Drug
Also called Aldesleukin
600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine + IL-2 | Experimental | One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses. Receives: Drug: Hydroxychloroquine; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 3 years
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 3 years
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 3 years
Secondary outcomes (18)
Overall Survival (OS)
Time from date of first protocol treatment until the date of death, or censored at date of last contact.
Measured: Up to 3 years
Progression-free Survival (PFS)
Time from the date of first protocol treatment until the date disease progression criteria are met (in responding patients progression criteria uses the reference of the smallest measurements recorded since the treatment started) or is censored at date of last disease assessment for those who have not progressed. Per RECIST 1.1, Progressive Disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 3 years
Number of Doses of IL-2 + HCQ
Number of doses of IL-2 administered during the first course of therapy.
Measured: Up to 3 years
Frequency of Grade III and Grade IV Toxicities
Number of specified categories of grade III and IV or unexpected or rare toxicities occurring during the first course (up until the end of cycle 1) of IL-2 treatment.
Measured: Up to 3 years
Worst Grade of Adverse Event Experienced
Number of participants who experienced Grade 2-5 adverse events.
Measured: Up to 3 years
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
Number of participants who experienced Grade 2-5 adverse events that were at least possibly related to study treatment.
Measured: Up to 3 years
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
Number of participants who experienced Grade 2-5 adverse events that were at least probably related to study treatment.
Measured: Up to 3 years
Serum Lactate Dehydrogenase
Number of participants with either high serum lactate dehydrogenase (> 1.5 times upper limit of normal) or normal lactate dehydrogenase.
Measured: Up to 2 years
Hemoglobin Levels
Low hemoglobin levels (less than the lower limit of normal (13.2 g/dL)) are considered to be unfavorable.
Measured: Up to 3 years
Serum Calcium Levels (Corrected)
Number of patients with either normal or high serum calcium levels. High serum calcium levels are considered to be clinically unfavorable.
Measured: Up to 3 years
Prior Nephrectomy
Number of patients with history of a prior nephrectomy (surgical removal of a kidney) or no history of a prior nephrectomy.
Measured: Up to 3 years
Number of Participants With Low Karnofsky Performance Status
Karnofsky performance status is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient should be included in the trial. A low Karnofsky performance status (<80%) is considered to be unfavorable.
Measured: Up to 3 years
Natural Killer (NK) Cells
Percentage of Natural Killer (NK) cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Measured: Up to 3 years
Myeloid Derived Suppressor Cell (MDSC)
Percentage of Myeloid Derived Suppressor Cell per ml of blood. MDSC immune cells originate from bone marrow stem cells and strongly expand in cancer.
Measured: Up to 3 years
Regulatory T Cells (Treg)
Percentage of Regulatory T cells per ml of blood. High levels of Tregs in the tumor microenvironment are associated with poor prognosis in many cancers by suppressing the body's anti-tumor immune response.
Measured: Up to 3 years
Plasmacytoid Dendritic Cells (pDC)
Percentage of Plasmacytoid dendritic cells per ml of blood. In cancer, pDC are malignant immune cells that demonstrate an impaired response that can contribute to the establishment of an immunosuppressive tumor microenvironment.
Measured: Up to 3 years
T-cell Lymphocytes
Percentage of T-cell lymphocytes in blood as cells per ml. T-cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer.
Measured: Up to 3 years
Conventional Dendritic Cells (cDC)
Percentage of Conventional Dendritic Cells (cDC) per ml of blood. cDC reside in tissues and once activated, migrate to draining lymph nodes to promote adaptive immune responses.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion6 Feb 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonard Appleman
- Sponsor type
- University, hospital or other
- Collaborators
- Prometheus Laboratories
- Responsible party
- Sponsor-investigator, Leonard Appleman, University of Pittsburgh
- Investigators
- Leonard J Appleman, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550367
- Sponsor's protocol ID
- UPCI 11-080
- Status last verified
- Dec 2019
- First submitted
- 29 Feb 2012
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibiting the Systemic Autophagic Syndrome - A Phase I/II Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC). A Cytokine Working Group (CWG) Study
- ClinicalTrials.gov ID
- NCT01550367
- Acronym / sponsor ID
- UPCI 11-080
- Conditions
- Metastatic Renal Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Leonard ApplemanUniversity, hospital or other
- Collaborators
- Prometheus Laboratories
- Study start
- Mar 2012
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the research study is to determine whether treating renal cell cancer patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of kidney cancer that has spread to other parts of the body, can make the cancer easier to kill and eliminate. Another goal is to see how the study drug affects the body's immune cells which fight cancer cells.
Detailed description
The rationale for combining the high dose bolus aldesleukin with hydroxychloroquine includes potential positive interactions on the immune regulatory side, non-overlapping toxicities, and potential for prolongation and increased number of responses based on murine studies conducted at the University of Pittsburgh. This study is a multi-center phase II study designed to estimate the efficacy of combination therapy of standard high dose bolus IL-2 and various doses of hydroxychloroquine therapy in metastatic RCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine + IL-2 | Experimental | Drug: Hydroxychloroquine, Drug: IL-2One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed metastatic renal cell carcinoma with predominantly clear cell histology.
- Have measurable disease by RECIST 1.1 criteria. For example, this would include tumor in the lung, liver, and retroperitoneum. Bone disease is difficult to follow and quantify and as a sole site would not be acceptable.
- Patients must be at least 4 weeks from radiation or surgery and recovered from all ill effects.
- Age ≥18 years.
- Karnofsky Performance Status ≥80%.
Key exclusion criteria (21 listed)
- Patients who have previously received IL-2 are NOT eligible. Patients on HCQ in neoadjuvant protocols or in the past for clinical indications ARE eligible, as are patients who have previously received CTLA-4 and/or PD-1/PD-L1 antibodies.
- Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence or breast CIS.
- In patients with a prior history of invasive malignancy, less than five years in complete remission.
- Positive serology for HIV, hepatitis B or hepatitis C.
- Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen.
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 |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilContinuous oral administration (at 600 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses. | Drug | Hydroxychloroquine + IL-2 |
| IL-2Also: Aldesleukin600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course | Drug | Hydroxychloroquine + IL-2 |
Primary outcome
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Time frame: Up to 3 years
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Time frame: Up to 3 years
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Time frame: Up to 3 years
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
18 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years
Progression-free Survival (PFS)
Time frame: Up to 3 years
Number of Doses of IL-2 + HCQ
Time frame: Up to 3 years
Frequency of Grade III and Grade IV Toxicities
Time frame: Up to 3 years
Worst Grade of Adverse Event Experienced
Time frame: Up to 3 years
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
Time frame: Up to 3 years
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
Time frame: Up to 3 years
Serum Lactate Dehydrogenase
Time frame: Up to 2 years
Hemoglobin Levels
Time frame: Up to 3 years
Serum Calcium Levels (Corrected)
Time frame: Up to 3 years
Prior Nephrectomy
Time frame: Up to 3 years
Number of Participants With Low Karnofsky Performance Status
Time frame: Up to 3 years
Natural Killer (NK) Cells
Time frame: Up to 3 years
Myeloid Derived Suppressor Cell (MDSC)
Time frame: Up to 3 years
Regulatory T Cells (Treg)
Time frame: Up to 3 years
Plasmacytoid Dendritic Cells (pDC)
Time frame: Up to 3 years
T-cell Lymphocytes
Time frame: Up to 3 years
Conventional Dendritic Cells (cDC)
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leonard J Appleman, MD, PhD principal investigator
University of Pittsburgh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydroxychloroquine and IL-2 in people with Metastatic Renal Cell Carcinoma, run by Leonard Appleman at 7 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 15 inclusion and 21 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: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. 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 2 Jan 2020.