EMD 121974 in Treating Patients With Locally Advanced or Metastatic Cancer

Lymphoma Clinical Trial

Official title:

A Phase I Trial of EMD 121974 in Patients With Advanced or Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004258
• Other study ID #: 9909-40; T99-0076
• Secondary ID: IUMC-9909-40NCI-
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2000
• Last updated: September 16, 2014
• Start date: December 1999
• Est. completion date: September 2001

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited Stated: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of EMD 121974 in treating patients who have locally advanced or metastatic cancer.

Description:

OBJECTIVES: I. Determine the safety and tolerability of EMD 121974 in patients with advanced or metastatic cancer. II. Correlate various surrogate markers of antiangiogenic activity with EMD 121974 therapy including magnetic resonance imaging and PET scans, serum assays for various angiogenic and antiangiogenic factors, serum and urine markers of calcium metabolism, and tumor biopsies.

OUTLINE: This is a dose-escalation study. Patients receive EMD 121974 IV over 1 hour twice weekly for 4 weeks. Treatment continues for an additional course in the absence of unacceptable toxicity. Patients with stable or responding disease may continue therapy indefinitely past the 2 courses until disease progression. Cohorts of 3-6 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 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, and then every 4 months thereafter until disease progression.

PROJECTED ACCRUAL: A total of 31-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic cancer that is considered incurable and for which no standard curative therapy exists No primary CNS malignancies Measurable evidence of residual, recurrent, or metastatic disease No prior CNS metastases with residual abnormal findings on neuroradiologic studies Prior CNS metastases allowed provided at least 6 months from definitive therapy and a normal CT or MRI of the brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 mg/dL (may be post transfusion) Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring parenteral antibiotics No documented abnormal CNS exam with seizure disorder or major neuropsychiatric problems

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior hematopoietic growth factor or cytokine therapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for steroid replacement therapy or chronic low dose (no greater than 10 mg/day oral prednisone) therapy for nonmalignant conditions No concurrent hormonal therapy except oral contraceptives or hormonal replacement therapy Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other: At least 4 weeks since other prior investigational drugs No concurrent oral or parenteral anticoagulants except anticoagulants for central venous catheters including low dose warfarin (1-2 mg/day) and/or heparin No concurrent oral COX-2 specific inhibitors (e.g., celecoxib or rofecoxib)

Study Design

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

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Neoplasm Metastasis
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Preleukemia
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• cilengitide
dose escalation of cilengitide

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of escalating doses of twice weekly EMD 121974 in patients with cancer.		enrollement through termination	Yes