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SarcomaPhase 2NCT01842594

A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma

A Phase 2 study testing Sirolimus and hydroxychloroquine in people with Sarcoma, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Sarcoma
What is being tested?
Sirolimus and hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteTaiwan
Study dates
Aug 2012to Jan 2015
Phase
Phase 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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Soft tissue sarcoma (including high grade or low grade soft tissue sarcoma、osteogenic sarcoma and the following 4 recurrent benign tumors which may have aggressive clinical course after initial surgical treatment : lymphangioleiomyomatosis、angiomyolipoma、giant cell tumor、phylloid tumor) that are refractory to at least first line full course of standard chemotherapy, relapsed after standard chemotherapy, or who have no standard therapy available and refused chemotherapy
  • Patients must be >/= 21 years.
  • Patients must be >/= 4 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >/= 5 half-lives or >/= 3 weeks form the last dose (whichever comes first).
  • Eastern Cooperative Oncology Group(ECOG) performance status </= 2
  • Patients must have certain organ and marrow function resave defined as: White blood cell(WBC_ >/= 3,000/mL;platelets >/=100,000/mL; creatinine </= 2 X Upper Limit of Normal (ULN); total bilirubin </= 2.0; Alanine Aminotransferase(ALT;SGPT) </= 5 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 8 X ULN;cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL (sirolimus and hydroxychloroquine only).
  • Patients must be able to understand and be willing to sign a written informed consent document.

Who cannot join

  • Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  • Pregnant or lactating women.
  • History of hypersensitivity to sirolimus.
  • History of hypersensitivity to hydroxychloroquine
  • Patients unwilling or unable to sign informed consent document.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, Taiwan, 11101

Other trials in Taiwan

About this study

Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus.

Read the detailed description

This study evaluates the daily morning single dose of hydroxychloroquine /sirolimus combined therapy in sarcoma patients. Study arm were treated with hydroxychloroquine 400 mg /sirolimus 2mg gd for 8-wk therapy. Patients will be discontinued from the study after 8-wk observation period.

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study.

TREATMENT PLAN:

  1. Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally every day. Treatment will be divided into time periods called cycles. Each treatment cycle is 28 days. The exception to this 28 day cycle is when participants start taking the pills for the first time. When the hydroxychloroquine and sirolimus begins, the first cycle of 28 days begins.
  2. There are several tests and procedures that will be performed at specific time periods during protocol treatment. These include: blood work, performance status assessment, questions about medical history and medications, tumor assessment with PET/CT or MRI and, eye exams.
  3. Dose modification criteria:

Participants may continue to receive study treatment as long as they experienced grade 1 or 2 side effects. The treatment drug will be 50% reduction of dose in any grade 3 toxicity; and discontinued of treatment (off-study) in any grade 4 toxicity or disease progression during treatment.

Conditions
Sarcoma
Being tested
Sirolimus and hydroxychloroquine
Keywords
Sarcoma, Hydroxychloroquine, Sirolimus, PET
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sirolimus and hydroxychloroquineDrug

    Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally QD for 2 cycles .

    Each treatment cycle is 28 days.

Study groups in NCT01842594
Study groupRoleWhat they receive
Sirolimus and hydroxychloroquineExperimentalBoth hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally once daily(QD) for 2 cycles . Each treatment cycle is 28 days.
Receives: Drug: Sirolimus and hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan

    A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.

    Measured: 2 Weeks

Secondary outcomes (1)

  1. The Toxicity

    Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.

    Measured: 2 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Most patients completed only the primary objective (PET) and not went throught the secondary outcome (efficacy phase) of 8wks period.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842594
Sponsor's protocol ID
20120306M
Status last verified
Oct 2015
First submitted
19 Dec 2012
Last updated
3 Nov 2015
Data monitoring committee
Yes

Publications

  • Chi MS, Lee CY, Huang SC, Yang KL, Ko HL, Chen YK, Chung CH, Liao KW, Chi KH. Double autophagy modulators reduce 2-deoxyglucose uptake in sarcoma patients. Oncotarget. 2015 Oct 6;6(30):29808-17. doi: 10.18632/oncotarget.5060.

    PubMed 26375670

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sirolimus and hydroxychloroquine in people with Sarcoma, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.

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 6 inclusion and 5 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 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 3 Nov 2015). 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?

The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842594, which also lists 1 linked publication.

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 3 Nov 2015.

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