Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's lymphoma, relapsed Hodgkin's lymphoma, refractory Hodgkin's lymphoma, Temsirolimus Read More

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.