Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Phase 1

Terminated

• Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Peripheral T-Cell Lymphoma; Post-transplant Lymphoproliferative Disorder
• Interventions: Drug: lenalidomide; Drug: vorinostat; Other: laboratory biomarker analysis

• Registration Number: NCT01116154
• Lead Sponsor: City of Hope Medical Center

Brief Summary

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vorinostat together with lenalidomide may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of the combination of lenalidomide and vorinostat.

II. To determine the maximum tolerated dose (MTD) and recommended dose of vorinostat and lenalidomide when given in combination in this patient population.

SECONDARY OBJECTIVES:

I. To obtain preliminary data for response rate, time to response, response duration and time to progression (TTP) for vorinostat and lenalidomide when used in combination.

OUTLINE: This is a dose-escalation study of vorinostat.

Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	vorinostat	Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm I	laboratory biomarker analysis	Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm I	lenalidomide	Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population	Following Cycle 1 of treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with Grade 3 or above adverse events	Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
Duration, intensity, and time to onset of toxicities	Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
AE, laboratory safety assessments, ECOG, ECGs, vital signs, transfusions, hospital days, and antibiotic use	Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
Objective response rate	Every nine weeks on therapy after 2 years a minimum of every 6 months
Time to response	Every nine weeks on therapy after 2 years a minimum of every 6 months
Response duration	Every nine weeks on therapy after 2 years a minimum of every 6 months
Progression-free survival	Every nine weeks on therapy after 2 years a minimum of every 6 months

Trial Locations

Locations (1)

City of Hope; 🇺🇸 Duarte, California, United States