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EMD 121974 in Treating Patients With Advanced Solid Tumors

A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022113
Enrollment
35
Registered
2003-01-27
Start date
2001-05-31
Completion date
Unknown
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Brief summary

Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor

Detailed description

OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors. II. Determine the biologic activity of this drug in these patients. III. Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients. IV. Determine, preliminarily, the antitumor efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-10 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 6 patients experience dose-limiting toxicity.

Interventions

DRUGcilengitide

Given IV

OTHERpharmacological study

Correlative studies

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists * Tumors must be amenable to minimally-invasive biopsy (i.e., tumors must be superficial enough to be sampled by punch biopsy or core biopsy procedure without radiologic guidance)\* * No uncontrolled brain metastases, including symptomatic lesions or lesions requiring glucocorticoids and/or anticonvulsants to suppress symptoms * Negative brain scan required if there are signs and symptoms suggestive of brain metastasis * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * At least 12 weeks * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No ongoing or active infection * No other concurrent serious systemic disorders (e.g., significant CNS illness) that would preclude study * No concurrent psychiatric illness or social situations that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent anticancer immunotherapy * Concurrent hematologic growth factors for cytopenias allowed * At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin) and recovered * See Disease Characteristics * No concurrent anticancer hormonal therapy * Concurrent oral contraceptives or postmenopausal hormone replacement allowed * Recovered from prior radiotherapy * At least 2 weeks since prior palliative radiotherapy to bone or brain metastases * At least 4 weeks since prior anticancer radiotherapy * No concurrent anticancer radiotherapy * Not specified * At least 4 weeks since prior anticancer therapy and recovered * At least 4 weeks since prior investigational agents * Any number of prior therapies allowed * No other concurrent anticancer investigational or commercial agents * No concurrent combination antiretroviral therapy for HIV-positive patients

Design outcomes

Primary

MeasureTime frameDescription
MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.4 weeksGraded according to the NCI Common Toxicity Criteria version 2.0.
Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatmentUp to 4 yearsGraded according to the NCI Common Toxicity Criteria version 2.0.
Biological activity of this regimenUp to 4 yearsMeasured buy TUNEL assay, CD31 immunohistochemistry, dynamic contrast-enhanced MRI, and FDG-PET scan.

Secondary

MeasureTime frame
Pharmacokinetics of cilengitideAt 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 24.0 hours post-end-of-infusion on day 1 of course 1
Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteriaUp to 4 years
Time to progressionUp to 4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026