EMD 121974 in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00022113

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cilengitide

Intervention Type: DRUG

Given IV

pharmacological study

Intervention Type: OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cilengitide

Given IV

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

EMD 121974; pharmacological studies

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Basche

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Denver, Colorado, United States

Countries

United States

Other Identifiers

00-1096

Identifier Type: -

Identifier Source: secondary_id

U01CA099176

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068786

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02392

Identifier Type: -

Identifier Source: org_study_id