Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Loyola University
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00838955
First received: February 6, 2009
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the toxicity of temsirolimus in this patient population. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • To estimate the time to progression after treatment with temsirolimus. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To estimate overall survival after treatment with temsirolimus. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temsirolimus
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
Drug: Temsirolimus
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838955

Contacts
Contact: Mary McCabe, MSN 708-327-3223 mmccabe@lumc.edu
Contact: Mary Lee, BSN 708-327-2241 mlee@lumc.edu

Locations
United States, Illinois
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Elaine Fluder, MSN    708-216-6198    efluder@lumc.edu   
Principal Investigator: Danielle Shafer, DO         
Sub-Investigator: Kevin Barton         
Sub-Investigator: Laura Michaelis         
Sub-Investigator: Sucha Nand         
Sub-Investigator: Tulio Rodriguez         
Sub-Investigator: Scott Smith         
Sub-Investigator: Patrick Stiff         
Sub-Investigator: David Vesole         
Sponsors and Collaborators
Loyola University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Danielle Shafer, DO Loyola University
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00838955     History of Changes
Other Study ID Numbers: 201170
Study First Received: February 6, 2009
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Hodgkin's lymphoma
relapsed Hodgkin's lymphoma
refractory Hodgkin's lymphoma
Temsirolimus

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014