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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Shin Kong Wu Ho-Su Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01842594
First received: December 19, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Sarcoma
Drug: Sirolimus and hydroxychloroquine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • The SUVmax change on PET/CT scan [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The SUVmax change on PET/CT scan before and after treatment.


Secondary Outcome Measures:
  • Tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Determine the objective response rate in sarcoma patients treated with daily morning single dose of hydroxychloroquine 400 mg and sirolimus 2mg for 8 weeks.

  • The toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The toxicity of hydroxychloroquine and sirolimus in this patient population.


Estimated Enrollment: 28
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus and hydroxychloroquine Drug: Sirolimus and hydroxychloroquine

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.


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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • ECOG performance status </= 2
  • Patients must have certain organ and marrow function resave defined as: WBC >/= 3,000/mL;platelets >/=100,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842594

Contacts
Contact: Kwan-Hwa Chi, M.D. 886-2-28332211 ext 2273 M006565@ms.skh.org.tw
Contact: Yu-Shan Wang, Ph.D 886-2-28332211 ext 2614 T006659@ms.skh.org.tw

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 11101
Contact: Su-Chen Huang, M.S.    886-2-28332211 ext 2612    A007267@ms.skh.org.tw   
Principal Investigator: Kwan-Hwa Chi, M.D.         
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
  More Information

No publications provided

Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01842594     History of Changes
Other Study ID Numbers: 20120306M
Study First Received: December 19, 2012
Last Updated: May 27, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Sarcoma, Hydroxychloroquine, Sirolimus, PET

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Hydroxychloroquine
Sirolimus
Everolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014