EMD 121974 in Treating Patients With Advanced Solid Tumors

NCT00022113 | Completed Phase 1

• 4 other identifiers: NCI-2012-0239200-1096U01CA099176CDR0000068786
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

  Graded according to the NCI Common Toxicity Criteria version 2.0.

  4 weeks

• Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatment

  Graded according to the NCI Common Toxicity Criteria version 2.0.

  Up to 4 years

• Biological activity of this regimen

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

  Up to 4 years

Secondary Outcomes (3)

• 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

• Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria

  Up to 4 years

• Time to progression

  Up to 4 years

Study Arms (1)

Treatment (cilengitide)

EXPERIMENTAL

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; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

cilengitide DRUG

Given IV

Also known as: EMD 121974

Treatment (cilengitide)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (cilengitide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cilengitide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

MeSH Terms

Interventions

Cilengitide

Study Officials

• Michele Basche

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Primary Completion: May 1, 2005
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)