Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

NCT00838955

Last updated date
Study Location
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hodgkin's Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed classical Hodgkin Lymphoma or Lymphocyte Predominant Hodgkin Lymphoma with progressive disease during or at the end of the previous therapy, as defined by the IWG criteria.

- Patient must have nodular sclerosing, lymphocyte depleted, or mixed cellularity Hodgkin Lymphoma (Classical Hodgkin Lymphoma), or Lymphocyte predominant Hodgkin Lymphoma.

- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.

- Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging.

- A clearly defined, bidimensionally measurable lymph node or tumor mass measuring at least 2 cm in diameter on a CT scan.

- Patient should have had at least one line of prior chemotherapy. Patients relapsing after treatment with radiation therapy alone are not eligible.

- Age > than or equal to 18 years.

- Both men and women and members of all races and ethnic groups are eligible for this trial.

- Women must not be pregnant or breast-feeding due to lack of information about the safety of administration of Temsirolimus in pregnant and lactating patients. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.

- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of pregnancy prevention.

- Patient must have a SWOG performance status between 0-2.

- Patient must have no prior treatment with an m-TOR inhibitor.

- Patient must not have active infections at the time of registration.

- Laboratory studies should be obtained within two weeks of study registration except where noted otherwise. Allowable laboratory values are listed below:

- Absolute neutrophil count > than or equal 1,000/mm3

- Hemoglobin > than or equal 8 gm/dL

- Platelets > than or equal 75,000/mm3

- Serum creatinine < than or equal to two times the upper limit of normal. Creatinine should be measured within seven days of registration.

- Total serum bilirubin < than or equal to ≤ 1.5 times the upper limit of normal. Total bilirubin should be measured within seven days of registration.

- AST (SGOT) < than or equal to 3 times the upper limit of normal.

- ALT (SGPT) < than or equal to 3 times the upper limit of normal.

- Fasting total cholesterol < than or equal to 350 mg/dL.

- Fasting triglyceride level < than or equal to 400 mg/dL.

- Patient must have a life expectancy of three months.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patient must not have received prior allogeneic stem cell transplantation. Prior
autologous stem cell transplantation more than six months prior to registration is
acceptable.


- Patient must not have received prior chemotherapy, biologic therapy or radiation
within three weeks prior to registration, and should have recovered from toxicities of
prior therapy (to Grade 0 or 1).


- Patient must not have evidence of active CNS disease.


- Patient must not have an uncontrolled comorbid disease, including hyperlipidemia,
hypertriglyceridemia, diabetes mellitus, symptomatic congestive heart failure,
unstable angina pectoris, or cardiac arrhythmia


- Patient must not have a psychiatric illness or social situation that would limit
compliance with study requirements.


- Patient must have a life expectancy of three months.

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Hodgkin's LymphomaTemsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
NCT00838955
  1. Maywood, Illinois
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Official Title  ICMJE Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Brief Summary This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
Detailed Description

Temsirolimus 25 mg IV infusion will be given once weekly on days 1, 8, 15 and 22 of each cycle. Patients will be assessed for response with CT scans after the second cycle, and then after every other cycle until disease progression is confirmed.

Patients will be treated with Temsirolimus until disease progression, or up to six cycles. Continuation of therapy beyond cycles is at the discretion of the investigator.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Lymphoma
Intervention  ICMJE Drug: Temsirolimus
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
Study Arms  ICMJE Experimental: Temsirolimus
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
Intervention: Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2009)
30
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed classical Hodgkin Lymphoma or Lymphocyte Predominant Hodgkin Lymphoma with progressive disease during or at the end of the previous therapy, as defined by the IWG criteria.
  • Patient must have nodular sclerosing, lymphocyte depleted, or mixed cellularity Hodgkin Lymphoma (Classical Hodgkin Lymphoma), or Lymphocyte predominant Hodgkin Lymphoma.
  • Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
  • Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging.
  • A clearly defined, bidimensionally measurable lymph node or tumor mass measuring at least 2 cm in diameter on a CT scan.
  • Patient should have had at least one line of prior chemotherapy. Patients relapsing after treatment with radiation therapy alone are not eligible.
  • Age > than or equal to 18 years.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.
  • Women must not be pregnant or breast-feeding due to lack of information about the safety of administration of Temsirolimus in pregnant and lactating patients. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of pregnancy prevention.
  • Patient must have a SWOG performance status between 0-2.
  • Patient must have no prior treatment with an m-TOR inhibitor.
  • Patient must not have active infections at the time of registration.
  • Laboratory studies should be obtained within two weeks of study registration except where noted otherwise. Allowable laboratory values are listed below:
  • Absolute neutrophil count > than or equal 1,000/mm3
  • Hemoglobin > than or equal 8 gm/dL
  • Platelets > than or equal 75,000/mm3
  • Serum creatinine < than or equal to two times the upper limit of normal. Creatinine should be measured within seven days of registration.
  • Total serum bilirubin < than or equal to ? 1.5 times the upper limit of normal. Total bilirubin should be measured within seven days of registration.
  • AST (SGOT) < than or equal to 3 times the upper limit of normal.
  • ALT (SGPT) < than or equal to 3 times the upper limit of normal.
  • Fasting total cholesterol < than or equal to 350 mg/dL.
  • Fasting triglyceride level < than or equal to 400 mg/dL.
  • Patient must have a life expectancy of three months.

Exclusion Criteria:

  • Patient must not have received prior allogeneic stem cell transplantation. Prior autologous stem cell transplantation more than six months prior to registration is acceptable.
  • Patient must not have received prior chemotherapy, biologic therapy or radiation within three weeks prior to registration, and should have recovered from toxicities of prior therapy (to Grade 0 or 1).
  • Patient must not have evidence of active CNS disease.
  • Patient must not have an uncontrolled comorbid disease, including hyperlipidemia, hypertriglyceridemia, diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Patient must not have a psychiatric illness or social situation that would limit compliance with study requirements.
  • Patient must have a life expectancy of three months.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838955
Other Study ID Numbers  ICMJE 201170
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathleen Phelan, Loyola University
Study Sponsor  ICMJE Loyola University
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Danielle Shafer, DOLoyola University
PRS Account Loyola University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP