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

NCT00348595 | Completed Phase 1 Results DMC

• 3 other identifiers: J0798RV-PCA-PI-069NA_00013597
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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 (prostatic specific antigen) 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 \[Prostatic Specific Antigen Doubling Time\] 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Safety, Feasibility and Tolerance of Revlimid as Assessed by Number of Participants Experiencing Grade 3 and 4 Adverse Events.

  Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0

  6 months post-intervention

• Number of Participants With Prostate-specific Antigen (PSA) Progression

  Number of participants with greater than or equal to 25% increase in PSA at 6 months

  6 months post-intervention

• Change in of PSA Slope

  Mean change in PSA slope from baseline to 6 months. PSA slope was calculated using the regression of log PSA over 6 months in each patient. A negative mean change in PSA slope reflects a better outcome.

  Change from baseline to 6 months post-intervention

Secondary Outcomes (1)

• Plasma Concentration of Revilimid at Steady State

  Day 21 of second treatment cycle

Study Arms (2)

1

ACTIVE COMPARATOR

5mg/day Arm: one 5 mg active Revlimid capsule and one 25 mg matched placebo capsules PO QAM (every morning) (at approximately the same time) days 1-21 days (28-day cycles).

Drug: Revlimid

2

ACTIVE COMPARATOR

25 mg/day Arm: one 25 mg active Revlimid capsule and one 5 mg matched placebo capsule PO QAM (every morning) (at approximately the same time) days 1-21 (28 day cycles).

Drug: Revlimid

Interventions

Revlimid DRUG

one 5 mg/day capsule or one 25 mg/day capsule with matched placebo capsule day 1-21 (28 day cycle)

Also known as: Lenalidomide

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (ASA 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Celgene Corporation: collaborator

Study Sites (1)

The Harry and Jeanette Weinberg Building

Baltimore, Maryland, 21230, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lenalidomide

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mario Eisenberger
• Organization: Johns Hopkins University School of Medicine

eisenma@jhmi.edu

(410) 614-3511

Study Officials

• Mario A Eisenberger, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: July 20, 2006
• Primary Completion: June 29, 2016
• Study Completion: June 29, 2016
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)