Treatment of Advanced Renal Cell Carcinoma With Quinacrine

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall response to standard therapies and to the newer antiangiogenesis therapies is not curative, and treatment-associated toxicities may be severe. Therefore, continued evaluation of therapies, with different mechanisms of action, is needed for patients with metastatic RCC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cleveland BioLabs
• Treatments: Quinacrine

Criteria

Inclusion Criteria:

• Confirmed RCC with clear cell predominance.

• Subjects must provide written informed .

• Subjects must be at least 18 years old.

• Subjects must have at least 1 measurable lesion.

• Subjects must have metastatic, locally advanced or unresectable RCC.

• Subjects must have received ≥ 1 prior systemic regimen for RCC.

• All prior cancer therapy, including radiation, surgery, and systemic (hormonal, chemotherapeutic, and immunotherapeutic) therapy, must be completed at least 4 weeks before the baseline visit.

• Subjects must be capable of adhering to the study visit schedule and other protocol requirements.

• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Subjects must have:

1. Absolute neutrophil count (ANC)> 1,500/uL

2. Hemoglobin > 10.0 g/dL

3. Platelets ≥ 100,000/uL

4. Serum creatinine < 2.0 mg/dL

• Subjects must have adequate hepatic function, as defined by a bilirubin level of ≤ 1.5 times the upper limit of the normal range (ULN) and an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level of ≤ 3 times the ULN (or ≤ 5 times the ULN if liver metastases are present).

• Women of childbearing potential must have a negative serum pregnancy test at the screening visit and throughout the study.

• Sexually active women and men must agree to use a medically acceptable form of contraception.

Exclusion Criteria:

• Subjects who have a history of any malignancy (other than excised basal cell carcinoma or cervical intraepithelial neoplasia) within the 5 years of baseline visit.

• Subjects who have received any anticancer agents, treatment (chemotherapy, targeted agents, radiation, hormones), or investigational agents within 30 days of the baseline visit.

• Subjects who have untreated brain metastases.

• Subjects who have a history of hypersensitivity reaction to quinacrine or other acridine derivatives (e.g. Cognex).

• Subjects who have any clinically significant hematological, endocrine, cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal (GI), or neurological disease (including any history of seizure).

• Subjects who have a history of porphyria or psoriasis.

• Subjects who have documented glucose-6-phosphate dehydrogenase deficiency.

• Subjects who have a history of noninfectious (toxic, autoimmune) hepatitis.

• Subjects who have a history of schizophrenia, bipolar disorder, or any psychiatric illness/social situations that would limit compliance with study requirements.

• Subjects who have a history of dermatitis as an allergic/toxic reaction to any medication.

• Subjects who have any grade 2 sensory neuropathy.

• Subjects who have a QTcF (Fredericia) of > 450 msec.

• Subjects who have New York Heart Association (NYHA) class 3 or 4 heart failure.

• Subjects who had a myocardial infarction or acute coronary syndrome within 6 months of the baseline visit.

• Subjects who require anti-arrhythmic treatment with amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning Automatic Implantable Cardio-Defibrillator (AICD) implanted.

• Subjects who are immunocompromised, including those known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.