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EMD 121974 in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00022113   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes

August 10, 2001
July 23, 2008
May 2002
 
 
 
Complete list of historical versions of study NCT00022113 on ClinicalTrials.gov Archive Site
 
 
 
EMD 121974 in Treating Patients With Advanced Solid Tumors
A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors

RATIONALE: EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors.

OBJECTIVES:

  • Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors.
  • Determine the biologic activity of this drug in these patients.
  • 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.
  • 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.

PROJECTED ACCRUAL: A total of 10-35 patients will be accrued for this study within 12-18 months.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cilengitide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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)* NOTE: *For at least 6 patients per cohort
  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No other concurrent anticancer immunotherapy
  • Concurrent hematologic growth factors for cytopenias allowed

Chemotherapy:

  • At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin) and recovered

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent anticancer hormonal therapy
  • Concurrent oral contraceptives or postmenopausal hormone replacement allowed

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022113
 
CDR0000068786, UCHSC-001096, NCI-3358
University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
Principal Investigator: Michele Basche, MD University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP