- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654186
Study Evaluating Toxicity & Efficacy of Lenalidomide(Revlimid®)in Chemotherapy-Naïve AIPC Patients
A Phase II Study Evaluating the Toxicity and Efficacy of Single Agent Lenalidomide (Revlimid®) in Chemotherapy-Naïve Androgen-Independent Prostate Cancer Patients
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Niles, Illinois, United States, 60714
- Oncology Specialists, S.C
-
Park Ridge, Illinois, United States, 60068
- Oncology Specialists, S.C
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Documented prostate cancer regardless of Gleason score
- Patients should be considered hormone refractory and androgen independent. They must fail LHRH analogues, and anti-androgen withdrawal trial. Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before, and confirmed by another assessment 2 weeks later that shows a further increase.
- Patients must have measurable disease either biochemically (using PSA) and/or using the RECIST criteria for visceral organ involvement and/or bone disease
- ECOG Performance Status of 2 or less.
- Adequate liver function tests with ALT/AST being < 3x normal, total bilirubin of 1.5 or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never exclusion criteria if it is deemed related to bone metastases.
Patients need to have adequate bone marrow function.
- ANC of 1000 or above,
- Hgb of 9.0 g/dl or above,
- Platelets of 100,000 or above. If other causes are affecting plts counts such as autoimmune disorders, patients are allowed on study. Patients with inadequate bone marrow function that is deemed related to bone marrow involvement with prostate cancer are allowed at the investigator's discretion.
- Patients with other malignancies are allowed as long as there is no evidence of the other malignancy present at entry time, and it has been 3 years or more since the treatment for the other disorder was completed.
- Patients with prior exposure to investigational therapies including vaccines are allowed on this study as long as their last exposure was 4 weeks prior to study entry. Erlotinib exposure and GM-CSF is not an exclusion criteria as it is not considered chemotherapy.
- Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa. Patients on oral bisphosphonates are also allowed.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Patients must agree to use a latex condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion Criteria:
- Prior systemic chemotherapy for AIPC. Investigational therapy such as vaccines, immunotherapy, and oral targeted agents such as erlotinib, sorafenib, or sunitinib are allowed.
- Prior exposure to lenalidomide
- Known HIV positive status
- Known brain metastases.
- Steroids are allowed concomitantly ONLY IF they are taken for another chronic medical condition (Such as COPD, Multiple sclerosis…etc)
- Presence of other malignancies, unless the last treatment received for any other malignancy was 3 years or more. Non-melanoma skin cancers are excluded.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- Known positive for HIV or infectious hepatitis, type A, B or C
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants
Time Frame: 24 months for acrual
|
The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions. Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%. |
24 months for acrual
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to PSA Progression
Time Frame: 24 months for acrual
|
As defined in the protocol PSA progression was an increase of at least 25%
|
24 months for acrual
|
Time to Disesase Progression as Measured by Radiographic Progression
Time Frame: 24 months
|
Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0.
PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- RV-PCA-PI-327
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 Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Revlimid
-
University Health Network, TorontoCelgene CorporationCompleted
-
Columbia UniversityCelgene CorporationActive, not recruiting
-
Johns Hopkins All Children's HospitalTerminatedCentral Nervous System TumorsUnited States
-
Beth Israel Deaconess Medical CenterAmerican Medical AssociationCompletedAcute Respiratory FailureUnited States
-
Massachusetts General HospitalCompletedHepatitis C | Kidney Disease, Chronic | Kidney FailureUnited States
-
CelgeneRecruitingMultiple MyelomaUnited States, France, Germany, Spain, United Kingdom, Italy
-
Dana-Farber Cancer InstituteCelgeneActive, not recruitingLangerhans Cell Histiocytosis (LCH) | Histiocytoses Erdheim-chester Disease | Histiocytic Sarcoma (HS)United States
-
Washington University School of MedicineCelgene CorporationCompletedHodgkin DiseaseUnited States
-
University of FloridaCelgene CorporationTerminatedMyelodysplastic Syndromes | Leukemia, MyeloidUnited States
-
Thomas KippsCelgene CorporationTerminatedChronic Lymphocytic LeukemiaUnited States