Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer

Condition(s) targeted: Prostate Cancer

Intervention: Revlimid (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Mario A Eisenberger, MD, Principal Investigator, Affiliation: Sidney Kimmel Comprehensive Cancer Center

Overall contact:
Judy Weber, R.N., Phone: 410-614-9526, Email: weberju@jhmi.edu

The primary objectives of the study are:

- To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at

5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of biochemical relapse (M0) following local treatment (i. e., surgery or radiation).

- To assess the rate of PSA progression at 6 months after treatment with 5mg/day and

25mg/day of Revlimid (CC-5013) in patients with evidence of biochemical relapse after local therapy.

The secondary objectives of the study are:

- To provide preliminary assessments on the effects of REvlimid (CC-5013) at 5mg/day and

25mg/day on various PSA constructs in the subject population (i. e., PSADT and PSA slope) by comparing pre and post treatment patterns in each arm.

- To evaluate preliminary pharmacodynamic correlations between serum revlimid

concentrations and toxicity, PSA constructs and other evidence of disease progression.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome:

The safety and tolerance of Revlimid (CC-5013 at 5mg/day and 25mg/day in

subjects with evidence of biochemically relapsed following local treatment

type, frequency, severity, and relationship of adverse events to study

treatment)

Disease progression measured as rate of PSA progression at 6 months, time to

disease progression and progression free survival.

Secondary outcome:

Effects of Revlimid (CC-5013) at 5mg/day and 25mg/day on various PSA

constructs (i.e., PSDT and PSA slope, time to PSA progression and PSA

decline)in subjects with evidence of biochemical relapse following

local therapy.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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 entry.

- 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

scan).

- 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

Judy Weber, R.N., Phone: 410-614-9526, Email: weberju@jhmi.edu

The Harry and Jeanette Weinberg Building, Baltimore, Maryland 21230, United States; Recruiting
Mario A. Eisenberger, MD, Phone: 410-614-3511, Email: eisenma@jhmi.edu
Victoria J. Sinibaldi, CRNP, Phone: 410-614-3209, Email: sinibvi@jhmi.edu
Mario A. Eisenberger, MD, Principal Investigator
Michael A. Carducci, MD, Sub-Investigator
Samuel Denmeade, MD, Sub-Investigator
Roberto Pili, MD, Sub-Investigator
Janet Walczak, CRNP, Sub-Investigator
Victoria J Sinibaldi, CRNP, Sub-Investigator
Virna I. Almuete, RPhD, Sub-Investigator
Susan Hudock, RPhD, Sub-Investigator
Judy Weber, RN, Sub-Investigator
Rana Sullivan, RN, Sub-Investigator
Connie Collins, RN, Sub-Investigator
Avery Spitz, RN, Sub-Investigator
Monica E. Taylor, RN, Sub-Investigator

Starting date: May 2006
Ending date: May 2008
Last updated: January 24, 2007