Know Cancer

forgot password

Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)
Hodgkin's Lymphoma

Thank you

Trial Information

Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

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.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus

Outcome Time Frame:

26 weeks

Safety Issue:


Principal Investigator

Danielle Shafer, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola University


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

January 2017

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's lymphoma
  • relapsed Hodgkin's lymphoma
  • refractory Hodgkin's lymphoma
  • Temsirolimus
  • Hodgkin Disease
  • Lymphoma



Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center Maywood, Illinois  60153