Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01144169|
Recruitment Status : Terminated (barriers to accrual: delay until surgery and additional pre-operative visits)
First Posted : June 15, 2010
Last Update Posted : October 26, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Hydroxychloroquine (HC)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB Study of Hydroxychloroquine Prior to Nephrectomy in Patients With Primary Renal Cell Carcinoma|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Hydroxychloroquine (HC)
HC orally for 14 days prior to nephrectomy
Drug: Hydroxychloroquine (HC)
Subjects will receive HC orally for 14 days prior to surgery. The fixed dose of HC will be 400 mg/day in divided doses (200 mg bid). The final dose will be administered on the evening prior to nephrectomy.
Other Name: Plaquenil®
- Measure biologic markers of autophagy in tumor and normal tissues (peripheral blood mononuclear cells, renal parenchyma) following a short course of pre-operative oral hydroxychloroquine [HC] in patients with renal cell carcinoma. [ Time Frame: Pre-hydroxychloroquine (HC), post-HC/pre-nephrectomy, post-nephrectomy (up to 1 month) ]
- Measure the serum biomarker response (HMGB1, sRAGE, VEGF, fibronectin, CRP, IL-6, nicotinamide N-methyltransferase, thrombospondin-1, CD 14, and ferritin) following pre-operative oral HC. [ Time Frame: One month post-nephrectomy ]
- Assess the effect of pre-operative HC on phenotype and function of DC and NK cells [ Time Frame: One month post-nephrectomy ]
- Assess the effect of pre-operative HC on abundance of neutrophils, NK cells, T-cells and T-cell subsets, PDCs and MDCs in the resected tumor, expression of CAIX and NOX4 compared with matched age/sex/histology matched controls. [ Time Frame: One month post-nephrectomy ]
- Assess miRNAs pre and post HC and postoperatively in blood and in resected tumor and normal kidney compared to stage- and grade-matched controls. [ Time Frame: Pre-HC, post-HC/pre-nephrectomy, post-nephrectomy (1 month) ]
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects with suspected primary or metastatic RCC (stage 1-IV) with planned nephrectomy or partial nephrectomy.
- ECOG performance status ≤1
Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:
- Serum creatinine level ≤1.5 the upper limits of normal (ULN)
- Serum total bilirubin level ≤1.5 X ULN
- White blood cell count > or = 3.5x109/ml per ml and platelet count ≥ 100x109 per ml
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- Subjects who have received chemotherapy for any diagnosis within 12 months prior to study entry.
- Prior use of radiotherapy or investigational agents for RCC.
- Concurrent malignancies with evidence of active or measurable disease except non-melanoma skin cancer
- Inability to adhere to study and/or follow-up procedures
- History of allergic reactions or hypersensitivity to the study drug (hydroxychloroquine) or current therapy with the study drug for other reasons.
- Other concurrent experimental therapy.
- The effects of HC on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well.
- HIV-positive patients are not excluded from the study. However, for patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HC is unknown. Therefore, HIV-positive patients actively receiving anti-retroviral therapy are excluded from the study.
- Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations.
- Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded. Hydroxychloroquine is known to affect the CYP2D6 metabolic pathway. A list of drugs with potential interaction is included in Appendix H.
- Patients with previously documented macular degeneration or diabetic retinopathy are excluded.
- Patients with known glucose-6-phosphate dehydrogenase (GP6D) deficiency
- EKG with QTc >500 msec at baseline (average of 3 determinations at 10 minutes interval). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144169
|United States, Pennsylvania|
|UPCI/UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|UPMC Department of Urology|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Jodi K. Maranchie, MD||University of Pittsburgh Medical Center|
|Responsible Party:||Jodi Maranchie, MD, FACS, University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||June 15, 2010 Key Record Dates|
|Last Update Posted:||October 26, 2016|
|Last Verified:||October 2016|
Renal cell carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Molecular Mechanisms of Pharmacological Action