ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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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Descriptive Information | ||||
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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 | 14 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
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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 |
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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 |