Back to resultsHydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
Primary Purpose
Bone Metastases, Unspecified Adult Solid Tumor, Protocol Specific
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hydroxychloroquine
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases
Eligibility Criteria
Inclusion Criteria:
- Patients must have a histologically confirmed solid tumor with radiographic evidence of bony metastatic disease and symptoms requiring palliative radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy of greater than 6 weeks
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin =< 1.5 X institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with calculated creatinine levels above institutional normal limits
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 4 weeks earlier
- Patients may not have received prior radiotherapy to the intended site
- Patients who have not recovered from acute adverse events due to previous radiotherapy
- Patients may not be receiving any other investigational agents
- Patients who are neurologically unstable due to uncontrolled brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - - History of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine
- 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
- Patients who are pregnant or may become pregnant during treatment
- Patients with severe psoriasis who may experience a flare of disease with hydroxychloroquine use
- Patients with known liver dysfunction (elevated transaminases or abnormal coagulation studies); patients with metastatic disease to the liver with normal liver function studies may be enrolled
- Patients with retinopathy
Sites / Locations
- Virginia Commonwealth University/Massey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (radiosensitization therapy)
Arm Description
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine PO QD or BID. Treatment continues until completion of radiotherapy.
Outcomes
Primary Outcome Measures
MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy
Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT01417403
First Posted
August 10, 2011
Last Updated
February 1, 2015
Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01417403
Brief Title
Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
Official Title
A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Recently published data that has shown HCQ to be safe when combined with chemo and or radiation at even higher doses than what is used in this study.
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase I trial studies the side effects and best dose of hydroxychloroquine in treating patients with solid tumors undergoing radiation therapy for bone metastases. Drugs, such as hydroxychloroquine, may make tumor cells more sensitive to radiation therapy
Detailed Description
OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of hydroxychloroquine that can safely be administered to cancer patients in association with radiation prior to developing this approach for disease treatment.
OUTLINE: This is a dose escalation study.
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine orally (PO) once daily (QD) or twice daily (BID). Treatment continues until completion of radiotherapy.
After completion of study treatment, patients are followed up at 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Unspecified Adult Solid Tumor, Protocol Specific
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (radiosensitization therapy)
Arm Type
Experimental
Arm Description
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine PO QD or BID. Treatment continues until completion of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Other Intervention Name(s)
HCQ
Intervention Description
Given PO
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiotherapy
Primary Outcome Measure Information:
Title
MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy
Description
Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have a histologically confirmed solid tumor with radiographic evidence of bony metastatic disease and symptoms requiring palliative radiotherapy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy of greater than 6 weeks
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin =< 1.5 X institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<2.5 X institutional upper limit of normal
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with calculated creatinine levels above institutional normal limits
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from acute adverse events due to agents administered more than 4 weeks earlier
Patients may not have received prior radiotherapy to the intended site
Patients who have not recovered from acute adverse events due to previous radiotherapy
Patients may not be receiving any other investigational agents
Patients who are neurologically unstable due to uncontrolled brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - - History of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine
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
Patients who are pregnant or may become pregnant during treatment
Patients with severe psoriasis who may experience a flare of disease with hydroxychloroquine use
Patients with known liver dysfunction (elevated transaminases or abnormal coagulation studies); patients with metastatic disease to the liver with normal liver function studies may be enrolled
Patients with retinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Cuttino
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.massey.vcu.edu/
Description
VCU Massey Cancer Center
Learn more about this trial
Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
We'll reach out to this number within 24 hrs