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A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Graded according to the NCI Common Toxicity Criteria version 2.0.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Michele Basche

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02392

NCT ID:

NCT00022113

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

University of ColoradoDenver, Colorado  80217