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EMD 121974 in Treating Patients With Advanced Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00022113
Collaborator
(none)
35
Enrollment
1
Location
1
Arm

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: cilengitide
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
 Phase 1

Detailed Description

OBJECTIVES:

  1. Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors.

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
Study Start Date :
May 1, 2001
Actual Primary Completion Date :
May 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (cilengitide)

Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: cilengitide
Given IV
Other Names:
  • EMD 121974

    • Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. [4 weeks]

      Graded according to the NCI Common Toxicity Criteria version 2.0.

    2. Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatment [Up to 4 years]

      Graded according to the NCI Common Toxicity Criteria version 2.0.

    3. Biological activity of this regimen [Up to 4 years]

      Measured buy TUNEL assay, CD31 immunohistochemistry, dynamic contrast-enhanced MRI, and FDG-PET scan.

    Secondary Outcome Measures

    1. Pharmacokinetics of cilengitide [At 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]

    2. Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria [Up to 4 years]

    3. Time to progression [Up to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Colorado United States 80217-3364

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Michele Basche, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00022113
    Other Study ID Numbers:
    • NCI-2012-02392
    • 00-1096
    • U01CA099176
    • CDR0000068786
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 25, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 25, 2013