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A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Drug Refractory Advanced Sarcoma

Phase 2
21 Years
75 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Drug Refractory Advanced Sarcoma

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.


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.

Inclusion Criteria:

- Patients with advanced or metastatic sarcoma 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).

- ECOG performance status
- Patients must have certain organ and marrow function resave defined as: WBC >/=
3,000/mL;platelets >/=100,000/mL; creatinine ALT(SGPT) mg/dL (sirolimus and hydroxychloroquine only).

- Patients must be able to understand and be willing to sign a written informed consent

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The SUVmax change on PET/CT scan

Outcome Description:

The SUVmax change on PET/CT scan before and after treatment.

Outcome Time Frame:

3 weeks

Safety Issue:



Taiwan: Department of Health

Study ID:




Start Date:

August 2012

Completion Date:

June 2014

Related Keywords:

  • Sarcoma
  • Sarcoma, Hydroxychloroquine, Sirolimus, PET
  • Sarcoma