Clinical trial NCT00420056: An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Official title: A Pilot Study Of Pd 0332991 In Patients With Previously Treated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Mantle-Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* Histologically documented MCL.
* Must have received at least one prior therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Adequate organ function as outlined in the protocol.

Exclusion Criteria:

* Major surgery, radiation therapy, or systemic therapy within 4 weeks of study enrollment.
* Prior radiation therapy to \>25% of the bone marrow (whole pelvis is 25%).
* Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.

Primary outcomes:
measure: Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
timeFrame: Baseline, Cycle 1 Day 21
measure: Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
timeFrame: Baseline, Cycle 1 Day 21
measure: Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21
timeFrame: Baseline, Cycle 1 Day 21
measure: Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)
timeFrame: Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS
measure: Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
timeFrame: Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR
measure: Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline
timeFrame: Baseline
measure: Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
timeFrame: Cycle 1 Day 21
measure: Ki-67 Composite Score at Baseline
timeFrame: Baseline
measure: Ki-67 Composite Score at Cycle 1 Day 21
timeFrame: Cycle 1 Day 21
measure: Cyclin D1 Composite Score at Baseline
timeFrame: Baseline
measure: Cyclin D1 Composite Score at Cycle 1 Day 21
timeFrame: Cycle 1 Day 21
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to 28 days after last dose of study medication
measure: Number of Participants With Treatment-Emergent Adverse Events by Severity
timeFrame: Day 1 up to 28 days after last dose of study medication
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 28 days after last dose of study medication
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)
measure: Percentage of Participants With Objective Response
timeFrame: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)
measure: Duration of Response (DR)
timeFrame: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)
measure: Time to Tumor Progression (TTP)
timeFrame: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)
measure: Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
timeFrame: Baseline, Cycle 1 Day 21
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University - New York Presbyterian Hospital
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.