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EMD 121974 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022113
First received: August 10, 2001
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: cilengitide
Other: pharmacological study
Other: laboratory biomarker analysis
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Graded 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 treatment [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
    Graded according to the NCI Common Toxicity Criteria version 2.0.

  • Biological activity of this regimen [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Measured buy TUNEL assay, CD31 immunohistochemistry, dynamic contrast-enhanced MRI, and FDG-PET scan.


Secondary Outcome Measures:
  • Pharmacokinetics of cilengitide [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2001
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EMD 121974
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022113

Locations
United States, Colorado
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
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022113     History of Changes
Other Study ID Numbers: NCI-2012-02392, 00-1096, U01CA099176, CDR0000068786
Study First Received: August 10, 2001
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013