Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer

NCT00417274 | Completed Phase 2 Results

• 1 other identifier: CBL-DD-05-C-H-2003
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.

Conditions

Prostatic Cancer

Keywords

Cancer of Prostate; Prostate Cancer; Cancer of the Prostate; Neoplasms, Prostate; Neoplasms, Prostatic; Prostate Neoplasms; Prostatic Cancer; Androgen-Independent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer

  Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator's discretion.

  End of treatment

Study Arms (1)

Quinacrine

EXPERIMENTAL

Uncontrolled treatment arm

Drug: Quinacrine

Interventions

Quinacrine DRUG

100 mg daily

Also known as: CBLB102

Quinacrine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be males, at least 18 years of age, with pathologically confirmed adenocarcinoma of the prostate
• Patients must have evidence of androgen-independent metastatic prostate cancer (AIMPC) following standard antiandrogen withdrawal. AIMPC will be defined as the category of patients with metastatic prostate cancer with radiologic evidence of metastases (bone scan, CT, etc.) and castrate levels of testosterone (\~ 50 ng/dL).
• All patients must be receiving ongoing therapy to ensure testicular androgen suppression (LHRH agonists therapy or bilateral orchiectomy).
• All patients receiving anti-androgen therapy \[e.g., flutamide (Eulexin), bicalutamide (Casodex), or nilutamide (Nilandron)\] must have initiated therapy at least 3 months (90 days) prior to the Baseline visit.
• Patients must have received prior docetaxel-based or mitoxantrone-based chemotherapy, or refused or been ineligible for chemotherapy. Previous chemotherapy treatments must be completed at least 4 week prior to Screening, and patients must not have any residual therapy-related toxicities present at Screening.
• Patients must have evidence of disease progression defined as any of the following:
• New sites of metastatic disease on radiographic imaging (bone scan or CT scan of chest/abdomen/pelvis) as determined by the referring physician.
• PSA progression, defined as a 50% or greater rise in PSA value over a baseline level of at least 1.0 ng/mL, confirmed after an interval of at least two weeks.
• ECOG performance status 0-2 (see Appendix 4)
• Patients must have adequate organ and bone marrow function as defined below:
• Absolute neutrophil count greater than 1500/mL
• Platelets greater than 100,000/mL
• Serum creatinine less than 2.0 mg/dL
• Total bilirubin less than 1.5 mg/dL
• AST (SGOT) and ALT (SGPT) less than 2 times the ULN \[less than 5 times the ULN if liver metastases are present\].

You may not qualify if:

• Prior allergic reactions or a history of intolerance attributed to quinacrine or other acridine derivatives
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hematological disorders, hepatic disease, or psychiatric illness/social situations that would limit compliance with study requirements.
• Lifetime history of porphyria or psoriasis
• Documented glucose-6-phosphate dehydrogenase deficiency
• Lifetime history of seizure disorder (except infant febrile seizures)
• Lifetime history of schizophrenia, bipolar disorder, or any other psychotic disorders.
• Lifetime history of dermatitis as an allergic/toxic reaction to any medication
• Clinical evidence of CNS metastases
• Patients with a history of any malignancy (other than basal, squamous cell cancers and Ta bladder cancers) within 5 years of baseline visit
• Any grade 2 sensory neuropathy
• QTc (Bazett) \>450 msec
• Patients with NYHA class 3 or 4 failure
• Patients with myocardial infarction or acute coronary syndrome within the previous 6 months
• Patients who require anti-arrhythmic treatment

Sponsors & Collaborators

• Cleveland BioLabs: lead

Related Publications (1)

• Gurova KV, Hill JE, Guo C, Prokvolit A, Burdelya LG, Samoylova E, Khodyakova AV, Ganapathi R, Ganapathi M, Tararova ND, Bosykh D, Lvovskiy D, Webb TR, Stark GR, Gudkov AV. Small molecules that reactivate p53 in renal cell carcinoma reveal a NF-kappaB-dependent mechanism of p53 suppression in tumors. Proc Natl Acad Sci U S A. 2005 Nov 29;102(48):17448-53. doi: 10.1073/pnas.0508888102. Epub 2005 Nov 15.

  PMID: 16287968 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Quinacrine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Kurman, MD
• Organization: Clevland BioLabs

mkurman@cbiolabs.com

716-849-6810

Study Officials

• Edwin Posadas, MD

  University of Chicago Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 29, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 11, 2013
• Results First Posted: April 11, 2013

Record last verified: 2012-09