Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metastases Unspecified Adult Solid Tumor, Protocol Specific |
Drug: hydroxychloroquine Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Hydroxychloroquine in Patients With Solid Tumors Receiving Radiotherapy for Bone Metastases |
- MTD of hydroxychloroquine that can be safely administered to cancer patients in association with radiotherapy [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Safety assessments weekly during treatment and at 4 weeks post-radiotherapy
| Estimated Enrollment: | 24 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (radiosensitization therapy)
Beginning 3 days before the initiation of radiotherapy, patients receive hydroxychloroquine PO QD or BID. Treatment continues until completion of radiotherapy.
|
Drug: hydroxychloroquine
Given PO
Other Name: HCQ
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Laurie W. Cuttino, MD | 804-287-4340 | lcuttino@mcvh-vcu.edu |
| Contact: Diane Holdford, RN | 804-828-0296 | djholdfo@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University/Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Laurie W. Cuttino 804-287-4340 lcuttino@mcvh-vcu.edu | |
| Contact: Diane J. Holdford, RN, BSN 804-828-0296 djholdfo@vcu.edu | |
| Principal Investigator: Laurie W. Cuttino | |
| Principal Investigator: | Laurie Cuttino | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01417403 History of Changes |
| Other Study ID Numbers: | MCC-13713, NCI-2011-02310, P30CA016059 |
| Study First Received: | August 10, 2011 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
Hydroxychloroquine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013