- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001446
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer.
An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically documented adenocarcinoma of the prostate. Confirmation by the Clinical Center Pathology Department required.
CT-defined soft tissue disease required for staging if prostate-specific antigen (PSA) less than 20 ng/mL.
Progressive hormone-refractory disease for 1 month prior to entry (and after withdrawal of any antiandrogens), documented by at least one of the following: 3 consecutive rising levels of PSA at least 1 week apart. 1 measurement at least 50% greater than PSA nadir after last therapy.
New bone metastasis on Tc-99 bone scintigraphy.
Progression of measurable or evaluable soft-tissue metastases.
Development of new area of disease. 25% increase in previously measured lesions.
Total androgen ablation required. Testosterone in castrate range.
Concurrent luteinizing hormone-releasing hormone (LHRH) agonist required if not surgically castrated.
No prior prostate irradiation or radical prostatectomy unless other biopsiable lesions available.
Urgent local problems corrected prior to entry (e.g., severe bone pain, spinal cord compression, urinary flow obstruction).
No brain metastases.
PRIOR/CONCURRENT THERAPY:
Thyroid replaced concurrent to start of study for patients with chemical hypothyroidism.
Thyroid replaced prior to study for patients with clinical hypothyroidism.
Biologic Therapy: At least 4 weeks since Biologic Therapy and recovered from all toxic effects.
Chemotherapy:
No prior suramin.
At least 4 weeks since chemotherapy and recovered from all toxic effects.
Endocrine Therapy:
See Disease Characteristics.
At least 4 weeks since hormonal therapy except LHRH agonist therapy.
Radiotherapy:
See Disease Characteristics.
At least 4 weeks since radiotherapy (6 weeks since strontium).
Surgery: See Disease Characteristics.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Life expectancy: More than 3 months.
Hematopoietic:
Absolute granulocyte count greater than 1,000/mm(3).
Platelet count greater than 75,000/mm(3).
Hemoglobin greater than 8.0 g/dL (transfusion allowed if requirement maintained for more than 30 days OR bleeding identified and treated).
Hepatic:
Bilirubin no greater than 1.5 times normal.
AST and ALT less than 2.5 times normal.
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 40 mL/min.
Proteinuria no greater than 2+ OR less than 500 mg/24 hr (except patients with ureteral stents).
BUN normal.
Electrolytes normal.
Urinalysis normal.
Cardiovascular:
No unstable or newly diagnosed angina.
No myocardial infarction within 6 months.
No NYHA class II-IV congestive heart failure.
Pulmonary:
No chronic obstructive lung disease requiring oxygen therapy.
Neurologic:
No clinically detectable peripheral neuropathy greater than grade 1.
No seizures within 10 years.
No anticonvulsants.
No requirement for sedatives or hypnotics.
OTHER:
Normal thyroid function tests at least 4 weeks prior to study and throughout study.
No concurrent anticoagulants.
No active infection.
Off antibiotics at least 1 week.
Ureteral stent or Foley catheter allowed with no antibiotics.
HIV negative.
No concurrent life-threatening illness.
No concurrent malignancies.
Ability to travel to the National Institutes of Health.
Adequate contraception required of sexually active patients and their partners during and for 2 months after therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bakay B, Nyhan WL. Binding of thalidomide by macromolecules in the fetal and maternal rat. J Pharmacol Exp Ther. 1968 Jun;161(2):348-60. No abstract available.
- Barnhill RL, McDougall AC. Thalidomide: use and possible mode of action in reactional lepromatous leprosy and in various other conditions. J Am Acad Dermatol. 1982 Sep;7(3):317-23. doi: 10.1016/s0190-9622(82)70118-5.
- Sissung TM, Danesi R, Kirkland CT, Baum CE, Ockers SB, Stein EV, Venzon D, Price DK, Figg WD. Estrogen receptor alpha and aromatase polymorphisms affect risk, prognosis, and therapeutic outcome in men with castration-resistant prostate cancer treated with docetaxel-based therapy. J Clin Endocrinol Metab. 2011 Feb;96(2):E368-72. doi: 10.1210/jc.2010-2070. Epub 2010 Nov 24.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- 950178
- 95-C-0178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostatic Neoplasm
-
National Cancer Institute (NCI)CompletedProstatic Neoplasms | Prostate Cancer | Neoplasm, Prostate | Neoplasm,ProstaticUnited States
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterCompletedProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Neoplasm of Uncertain BehaviorUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
-
Centre Hospitalier Universitaire de BesanconRecruiting
-
Fondazione del Piemonte per l'OncologiaCompleted
-
AbbottCompletedProstatic NeoplasmBelgium, Luxembourg
-
Mayo ClinicCompletedProstatic NeoplasmUnited States
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaCompleted
-
Advanced Accelerator ApplicationsTerminatedProstatic NeoplasmUnited States, Spain
-
Sismanoglio General HospitalNational and Kapodistrian University of AthensCompletedProstatic NeoplasmGreece
Clinical Trials on thalidomide
-
Henan Cancer HospitalFirst Affiliated Hospital Xi'an Jiaotong UniversityRecruitingEsophageal Carcinoma | Lung Cancer, Nonsmall CellChina
-
Norwegian University of Science and TechnologyThe Research Council of Norway; Nordic Myeloma Study Group, GermanyCompleted
-
Changzhou No.2 People's HospitalUnknownEsophageal CancerChina
-
Shanghai Pharmaceuticals Holding Co., LtdCompletedAnkylosing SpondylitisChina
-
Shanghai Jiao Tong University School of MedicineChanghai Hospital; Peking Union Medical College Hospital; Shanghai Zhongshan... and other collaboratorsCompletedGastrointestinal Vascular MalformationChina
-
Valme University HospitalUniversity of SevilleUnknown
-
G.V. (Sonny) Montgomery VA Medical CenterUnknownHepatitis C Virus Infection | Infection | Herpesvirus 2, HumanUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Roswell Park Cancer InstituteCompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Graft Versus Host DiseaseUnited States
-
Washington University School of MedicineCelgene CorporationCompleted