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Phase I/II Double Blinded Randomized Study to Determine the Tolerability and Efficacy of 2 Different Doses of Revlimid (CC-5013, Lenalidomide) in Biochemically Relapsed Prostate Cancer Patients (M0) After Local Treatment

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase I/II Double Blinded Randomized Study to Determine the Tolerability and Efficacy of 2 Different Doses of Revlimid (CC-5013, Lenalidomide) in Biochemically Relapsed Prostate Cancer Patients (M0) After Local Treatment

Carcinoma of the prostate in the most commonly diagnosed malignancy among men in this
country with approximately 232,090 new cases expected to be diagnosed in 2005.
Unfortunately, despite local treatment, many men will demonstrate evidence of PSA
recurrence. At the present time, there is no standard treatment fo these patients. The
management of patients with PSA recurrence remains greatly controversial. Androgen
deprivation is frequently employed in patients with evidence of rising PSA levels despite
the fact that the effects on quantity and quality of life of androgen deprivation therapy at
this stage, remains un-established. Toxicity of androgen deprivation therapy is a major
factor to be considered in the decision process of employing the modality of treatment in
patients with no symptoms associated with this disease. Because patients with biochemical
relapse are mostly asymptomatic and typically have long survivals and disease free
survivals, mush of the focus of new drug development has been with the use of non-cytotoxic
compounds. This study is intended to provide preliminary evidence of a biological effect in
a dose response manner assessing the effects of Revlimid (CC-5013) on PSA.

Inclusion Criteria:

- Histologically confirmed diagnosis of adenocarcinoma of the prostate (M0) with
evidence of biochemical relapse after local therapy (i.e., surgery, radiation
therapy, or both.) Baseline PSA must be greater or equal to 1 ng/ml.

- Confirmed rise in PSA shown by 2 PSA values at least 1 month apart, higher than a
reference value noted within 6 months of study entry. Interim PSA values during the
immediate pre-study six-month interval may demonstrate a "fluctuation" including a
decline, however the study baseline PSA must have shown a rise within the pre-study
6-months period. Baseline PSA's must be determined within 4 weeks of study entry.

- All previous local modalities of treatment, including radiation and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study. May have
received prior systemic chemotherapy, hormonal therapy, biologic or vaccine therapy.
All treatment must have been discontinued for more than 6 months prior to study

- Patients receiving intermittent hormonal therapy for their rising PSA state are
considered eligible if testosterone level is above 150 ng/dl and treatment was
discontinued greater than 6 months

- No clinical or radiological evidence of distant metastases (excluding prostascint

- Serum testosterone > 150 ng/ml

- Disease free of prior malignancies for more than 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of
the breast.

- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
intolerant to ASA may use low molecular weight heparin). Lenalidomide increases the
risk of thrombotic events in patients who are at high risk or with a history a
thrombosis, in particular when combined with other drugs known to cause thrombosis.

Exclusion Criteria:

- 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/she were to participate in the study or confounds
the ability to interpret data from the study.

- Known hypersensitivity to thalidomide.

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

- Any prior use of Revlimid® (CC-5013).

- Concurrent use of other anti-cancer agents or treatments.

- Known brain metastases.

- Known positive for HIV or infectious hepatitis, type A, B or C.

- Any evidence of metastatic disease.

- Any increase in PSA while receiving neo-adjuvant or adjuvant therapy or intermittent
hormonal therapy.

- More than one prior biologic or vaccine therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Study feasibility, safety, tolerance, rate of PSA PD of Revlimid at 6 months.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Mario A Eisenberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



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