Endostatin in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00004229

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31

Brief Summary

Phase I trial to study the effectiveness of endostatin in treating patients who have advanced solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.

Detailed Description

OBJECTIVES:

I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors.

II. Determine the safety and tolerability of this regimen in these patients. III. Determine the extent, frequency, and duration of tumor response in these patients on this regimen.

IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients.

V. Determine the recommended phase II dose and schedule of this regimen.

OUTLINE: This is a dose escalation study.

Patients undergo a biopsy during prestudy and after the second course of treatment. Patients receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over 20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of endostatin 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.

Patients are followed for 1 month.

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

Arm I

Patients undergo a biopsy during prestudy and after the second course of treatment. Patients receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over 20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of endostatin 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.

Group Type: EXPERIMENTAL

recombinant human endostatin

Intervention Type: BIOLOGICAL

Interventions

recombinant human endostatin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven advanced solid tumor for which no standard curative therapy exists
• Must be amenable to biopsy At least 1 site of measurable disease outside of irradiated field
• No brain metastases by CT or MRI scan

PATIENT CHARACTERISTICS:

• Age: 18 and over
• Performance status: ECOG 0-1
• WBC greater than 3,000/mm3
• Absolute neutrophil count greater than 1,500/mm3
• Platelet count greater than 100,000/mm3
• Hemoglobin greater than 10 g/dL
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• ALT and AST less than 2.0 times ULN
• PT/PTT less than 1.5 times ULN
• Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent uncontrolled medical or psychiatric disorder
• No history of bleeding diathesis

PRIOR CONCURRENT THERAPY:

• No concurrent over the counter biologic agents (e.g., shark cartilage)
• At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin)
• No more than 3 prior chemotherapy regimens for metastatic or recurrent disease (ECOG 1)
• Prior adjuvant chemotherapy for nonmetastatic disease allowed
• Concurrent stable dose of hormone replacement therapy allowed
• At least 3 weeks since prior radiotherapy
• No concurrent radiotherapy
• At least 24 hours since minor surgery (e.g., central venous placement)
• At least 4 weeks since major surgery (e.g., laparotomy, thoracotomy, or craniotomy)
• At least 30 days since other prior investigational agents
• No concurrent herbal remedies
• No concurrent usage of products containing heparin
• No other concurrent anticancer therapy
• Concurrent multivitamins allowed

• 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

Roy S. Herbst, MD, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-99201

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0087

Identifier Type: -

Identifier Source: secondary_id

CDR0000067471

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02314

Identifier Type: -

Identifier Source: org_study_id