Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma

NCT00838955 | Terminated Phase 2 DMC

• 1 other identifier: 201170
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  26 weeks

Secondary Outcomes (3)

• To evaluate the toxicity of temsirolimus in this patient population.

  26 weeks

• To estimate the time to progression after treatment with temsirolimus.

  5 years

• To estimate overall survival after treatment with temsirolimus.

  5 years

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle

Drug: Temsirolimus

Interventions

Temsirolimus DRUG

Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle

Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Patrick Hagen, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (1)