EMD 121974 in Treating Patients With Advanced Solid Tumors

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Other: laboratory biomarker analysis

Other: pharmacological study

Drug: cilengitide

Study type

Interventional

Funder types

NIH

Identifiers

NCT00022113

NCI-2012-02392

U01CA099176 (U.S. NIH Grant/Contract)

00-1096

CDR0000068786 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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