Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases

NCT ID: NCT01417403

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Bone Metastases; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (radiosensitization therapy)

Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine PO QD or BID. Treatment continues until completion of radiotherapy.

Group Type: EXPERIMENTAL

hydroxychloroquine

Intervention Type: DRUG

Given PO

radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Interventions

hydroxychloroquine

Given PO

Intervention Type: DRUG

radiation therapy

Undergo radiotherapy

Intervention Type: RADIATION

Other Intervention Names

HCQ; irradiation; radiotherapy; therapy, radiation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Cuttino

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Related Links

http://www.massey.vcu.edu/

VCU Massey Cancer Center

Other Identifiers

NCI-2011-02310

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-13713

Identifier Type: -

Identifier Source: org_study_id