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Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma

Primary Purpose

AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Anaplastic Large Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cilengitide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS-related Peripheral/Systemic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed solid tumor or lymphoma Refractory to standard therapy or no standard therapy exists Measurable or evaluable disease No active brain metastases Previously treated brain metastases allowed provided the patient is not currently receiving corticosteroids Primary brain neoplasms allowed, regardless of corticosteroid use Performance status - Karnofsky 70-100% WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No life-threatening bleeding diathesis within the past 6 months Bilirubin normal (unless due to Gilbert's syndrome) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No prior proven gastric or duodenal ulcer No clinically significant gastrointestinal blood loss within the past 6 weeks Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior CNS hemorrhage No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No ongoing or active infection No prior cilengitide (EMD 121974) No other concurrent biologic therapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy No other concurrent anticancer agents or therapies intended to treat the malignancy No other concurrent investigational agents No concurrent anticoagulation therapy that increases INR or aPTT above the normal range Line prophylaxis allowed

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cilengitide)

Arm Description

Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Outcomes

Primary Outcome Measures

Maximum feasible dose defined as the highest dose studied for which the incidence of DLT is less than 33% or the highest safe dose in our study, limited to a maximum MFD dose of 40 mg/hr

Secondary Outcome Measures

Pharmacokinetics of EMD 121974

Full Information

First Posted
February 10, 2004
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077155
Brief Title
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
Official Title
A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer
Detailed Description
PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma. II. Determine the safety and tolerability of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of this drug in these patients. II. Determine the antineoplastic activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (cilengitide)
Arm Type
Experimental
Arm Description
Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Intervention Type
Drug
Intervention Name(s)
cilengitide
Other Intervention Name(s)
EMD 121974
Primary Outcome Measure Information:
Title
Maximum feasible dose defined as the highest dose studied for which the incidence of DLT is less than 33% or the highest safe dose in our study, limited to a maximum MFD dose of 40 mg/hr
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics of EMD 121974
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid tumor or lymphoma Refractory to standard therapy or no standard therapy exists Measurable or evaluable disease No active brain metastases Previously treated brain metastases allowed provided the patient is not currently receiving corticosteroids Primary brain neoplasms allowed, regardless of corticosteroid use Performance status - Karnofsky 70-100% WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No life-threatening bleeding diathesis within the past 6 months Bilirubin normal (unless due to Gilbert's syndrome) No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No prior proven gastric or duodenal ulcer No clinically significant gastrointestinal blood loss within the past 6 weeks Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior CNS hemorrhage No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness No ongoing or active infection No prior cilengitide (EMD 121974) No other concurrent biologic therapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No concurrent palliative radiotherapy No other concurrent anticancer agents or therapies intended to treat the malignancy No other concurrent investigational agents No concurrent anticoagulation therapy that increases INR or aPTT above the normal range Line prophylaxis allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Undevia
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

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Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma

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