Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hodgkin's Lymphoma	Drug: Temsirolimus	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Study Start Date :	January 2009
Estimated Primary Completion Date :	January 2014
Estimated Study Completion Date :	January 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus [ Time Frame: 26 weeks ]

Secondary Outcome Measures :

1. To evaluate the toxicity of temsirolimus in this patient population. [ Time Frame: 26 weeks ]
2. To estimate the time to progression after treatment with temsirolimus. [ Time Frame: 5 years ]
3. To estimate overall survival after treatment with temsirolimus. [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Loyola University
ClinicalTrials.gov Identifier:	NCT00838955 History of Changes
Other Study ID Numbers:	201170
First Posted:	February 9, 2009
Last Update Posted:	October 30, 2012
Last Verified:	October 2012

Keywords provided by Loyola University:

Hodgkin's lymphoma; relapsed Hodgkin's lymphoma; refractory Hodgkin's lymphoma; Temsirolimus

Additional relevant MeSH terms:

Lymphoma; Hodgkin Disease; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Everolimus	Sirolimus; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents