Clinical trial NCT00022113: EMD 121974 in Treating Patients With Advanced Solid Tumors
Official title: A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
timeFrame: 4 weeks
measure: Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatment
timeFrame: Up to 4 years
measure: Biological activity of this regimen
timeFrame: Up to 4 years
Secondary outcomes:
measure: Pharmacokinetics of cilengitide
timeFrame: 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
measure: Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria
timeFrame: Up to 4 years
measure: Time to progression
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michele Basche
role: PRINCIPAL_INVESTIGATOR
References: